Trial Outcomes & Findings for A Study of TAK-981 in People With Advanced Solid Tumors or Cancers in the Immune System (NCT NCT03648372)
NCT ID: NCT03648372
Last Updated: 2024-11-19
Results Overview
TEAEs were adverse events (AEs) that occurred after administration of the first dose of any study drug and through 30 days after the last dose of any 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. Any abnormal laboratory results were considered as TEAEs.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
109 participants
Primary outcome timeframe
From the first dose of study drug through 30 days after the last dose of study drug (up to 35.3 months)
Results posted on
2024-11-19
Participant Flow
Participants took part in the study at 17 investigative sites in Poland, Belgium, Spain, the United States and China from 01 October 2018 to 14 December 2023.
Participants were enrolled in Phase 1 (Dose Escalation) and in Phase 2 (Dose Expansion) to receive TAK-981 doses.
Participant milestones
| Measure |
Phase 1, Dose Escalation: TAK-981 3 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 3 milligram (mg), infusion, intravenously, twice weekly (BIW) on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 6 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 6 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 10 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 10 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 15 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 15 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 25 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 25 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 40 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 40 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, once weekly (QW) on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 75 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 75 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW on Days 1, 8, 15
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1, 8 and 15 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort A, NSCLC: TAK-981 90 mg BIW
Participants with non-squamous non-small cell lung cancer (NSCLC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort B, Cervical Cancer: TAK-981 90 mg BIW
Participants with cervical cancer received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort C, MSS-CRC: TAK-981 90 mg BIW
Participants with microsatellite-stable colorectal cancer (MSS-CRC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort D, DLBCL After CAR T-cells Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) progressed or relapsed after chimeric antigen receptor (CAR) T-cell therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort E, DLBCL Without Prior Cellular Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory DLBCL that have not received prior cellular therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort F, Follicular Lymphoma: TAK-981 90 mg BIW
Participants with relapsed/refractory follicular lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
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3
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4
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3
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4
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4
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7
|
6
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6
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6
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8
|
7
|
7
|
8
|
6
|
7
|
3
|
7
|
4
|
3
|
1
|
|
Overall Study
COMPLETED
|
1
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0
|
0
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0
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1
|
1
|
2
|
1
|
1
|
1
|
2
|
2
|
1
|
1
|
0
|
1
|
1
|
1
|
4
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
4
|
3
|
3
|
3
|
5
|
5
|
5
|
5
|
6
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5
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6
|
7
|
6
|
6
|
2
|
6
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0
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1
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0
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Reasons for withdrawal
| Measure |
Phase 1, Dose Escalation: TAK-981 3 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 3 milligram (mg), infusion, intravenously, twice weekly (BIW) on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 6 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 6 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 10 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 10 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 15 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 15 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 25 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 25 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 40 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 40 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, once weekly (QW) on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 75 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 75 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW on Days 1, 8, 15
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1, 8 and 15 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort A, NSCLC: TAK-981 90 mg BIW
Participants with non-squamous non-small cell lung cancer (NSCLC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort B, Cervical Cancer: TAK-981 90 mg BIW
Participants with cervical cancer received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort C, MSS-CRC: TAK-981 90 mg BIW
Participants with microsatellite-stable colorectal cancer (MSS-CRC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort D, DLBCL After CAR T-cells Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) progressed or relapsed after chimeric antigen receptor (CAR) T-cell therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort E, DLBCL Without Prior Cellular Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory DLBCL that have not received prior cellular therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort F, Follicular Lymphoma: TAK-981 90 mg BIW
Participants with relapsed/refractory follicular lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
0
|
0
|
1
|
2
|
0
|
0
|
0
|
2
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0
|
2
|
0
|
0
|
0
|
1
|
0
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0
|
0
|
0
|
|
Overall Study
Progressive Disease
|
2
|
3
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4
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3
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2
|
2
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3
|
3
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5
|
5
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2
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3
|
3
|
3
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Other
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
1
|
3
|
0
|
5
|
1
|
5
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Start of a New Systemic Treatment
|
0
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0
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0
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0
|
0
|
0
|
0
|
2
|
0
|
0
|
1
|
0
|
0
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0
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0
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0
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0
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0
|
0
|
0
|
0
|
Baseline Characteristics
A Study of TAK-981 in People With Advanced Solid Tumors or Cancers in the Immune System
Baseline characteristics by cohort
| Measure |
Phase 1, Dose Escalation: TAK-981 3 mg BIW
n=5 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 3 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 6 mg BIW
n=3 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 6 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 10 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 10 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 15 mg BIW
n=3 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 15 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 25 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 25 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 40 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 40 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg BIW
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg QW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 75 mg BIW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 75 mg QW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg BIW
n=8 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW on Days 1, 8, 15
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1, 8 and 15 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg BIW
n=8 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg QW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort A, NSCLC: TAK-981 90 mg BIW
n=7 Participants
Participants with non-squamous non-small cell lung cancer (NSCLC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort B, Cervical Cancer: TAK-981 90 mg BIW
n=3 Participants
Participants with cervical cancer received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort C, MSS-CRC: TAK-981 90 mg BIW
n=7 Participants
Participants with microsatellite-stable colorectal cancer (MSS-CRC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort D, DLBCL After CAR T-cells Therapy: TAK-981 90 mg BIW
n=4 Participants
Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) progressed or relapsed after chimeric antigen receptor (CAR) T-cell therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort E, DLBCL Without Prior Cellular Therapy: TAK-981 90 mg BIW
n=3 Participants
Participants with relapsed/refractory DLBCL that have not received prior cellular therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort F, Follicular Lymphoma: TAK-981 90 mg BIW
n=1 Participants
Participants with relapsed/refractory follicular lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Total
n=109 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
59.8 years
STANDARD_DEVIATION 9.78 • n=5 Participants
|
61.0 years
STANDARD_DEVIATION 14.73 • n=7 Participants
|
52.0 years
STANDARD_DEVIATION 11.05 • n=5 Participants
|
66.7 years
STANDARD_DEVIATION 10.69 • n=4 Participants
|
59.5 years
STANDARD_DEVIATION 5.80 • n=21 Participants
|
65.0 years
STANDARD_DEVIATION 4.69 • n=10 Participants
|
59.3 years
STANDARD_DEVIATION 10.21 • n=115 Participants
|
62.5 years
STANDARD_DEVIATION 9.07 • n=24 Participants
|
60.8 years
STANDARD_DEVIATION 10.87 • n=42 Participants
|
62.3 years
STANDARD_DEVIATION 10.97 • n=42 Participants
|
60.5 years
STANDARD_DEVIATION 9.56 • n=42 Participants
|
62.4 years
STANDARD_DEVIATION 14.21 • n=42 Participants
|
64.4 years
STANDARD_DEVIATION 7.93 • n=36 Participants
|
59.4 years
STANDARD_DEVIATION 11.02 • n=36 Participants
|
57.8 years
STANDARD_DEVIATION 8.33 • n=24 Participants
|
64.0 years
STANDARD_DEVIATION 6.98 • n=135 Participants
|
53.3 years
STANDARD_DEVIATION 2.08 • n=136 Participants
|
51.6 years
STANDARD_DEVIATION 13.02 • n=44 Participants
|
56.3 years
STANDARD_DEVIATION 18.06 • n=667 Participants
|
71.7 years
STANDARD_DEVIATION 5.51 • n=7 Participants
|
53.0 years
STANDARD_DEVIATION NA • n=6 Participants
|
60.3 years
STANDARD_DEVIATION 10.3 • n=10 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
4 Participants
n=36 Participants
|
3 Participants
n=36 Participants
|
5 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
3 Participants
n=136 Participants
|
3 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=6 Participants
|
58 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
4 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
5 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
6 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
4 Participants
n=44 Participants
|
4 Participants
n=667 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
51 Participants
n=10 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
|
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
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
6 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=36 Participants
|
6 Participants
n=36 Participants
|
5 Participants
n=24 Participants
|
7 Participants
n=135 Participants
|
3 Participants
n=136 Participants
|
7 Participants
n=44 Participants
|
4 Participants
n=667 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=6 Participants
|
100 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 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
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
6 Participants
n=10 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
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
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
|
1 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
2 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=6 Participants
|
6 Participants
n=10 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
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=10 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
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
9 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
4 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
7 Participants
n=36 Participants
|
5 Participants
n=36 Participants
|
5 Participants
n=24 Participants
|
7 Participants
n=135 Participants
|
3 Participants
n=136 Participants
|
2 Participants
n=44 Participants
|
4 Participants
n=667 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
88 Participants
n=10 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
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=10 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
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
5 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: From the first dose of study drug through 30 days after the last dose of study drug (up to 35.3 months)Population: Safety analysis set consisted of participants who received at least 1 dose, even if incomplete, of study drug.
TEAEs were adverse events (AEs) that occurred after administration of the first dose of any study drug and through 30 days after the last dose of any 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. Any abnormal laboratory results were considered as TEAEs.
Outcome measures
| Measure |
Phase 1, Dose Escalation: TAK-981 75 mg QW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg BIW
n=8 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW on Days 1, 8, 15
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1, 8 and 15 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg BIW
n=8 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg QW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort A, NSCLC: TAK-981 90 mg BIW
Participants with non-squamous non-small cell lung cancer (NSCLC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort B, Cervical Cancer: TAK-981 90 mg BIW
Participants with cervical cancer received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 3 mg BIW
n=5 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 3 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 6 mg BIW
n=3 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 6 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 10 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 10 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 15 mg BIW
n=3 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 15 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 25 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 25 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 40 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 40 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg BIW
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg QW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 75 mg BIW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort C, MSS-CRC: TAK-981 90 mg BIW
Participants with microsatellite-stable colorectal cancer (MSS-CRC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort D, DLBCL After CAR T-cells Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) progressed or relapsed after chimeric antigen receptor (CAR) T-cell therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort E, DLBCL Without Prior Cellular Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory DLBCL that have not received prior cellular therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort F, Follicular Lymphoma: TAK-981 90 mg BIW
Participants with relapsed/refractory follicular lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Number of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs)
|
6 Participants
|
8 Participants
|
7 Participants
|
7 Participants
|
8 Participants
|
6 Participants
|
—
|
—
|
4 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
6 Participants
|
6 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From the first dose of study drug through 30 days after the last dose of study drug (up to 35.3 months)Population: Safety analysis set consisted of participants who received at least 1 dose, even if incomplete, of study drug.
The 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. Where Grade 3 was severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living (ADL), Grade 4 was life-threatening consequences; urgent intervention indicated, and Grade 5 was death related to AE. TEAEs were AEs that occurred after administration of the first dose of any study drug and through 30 days after the last dose of any study drug.
Outcome measures
| Measure |
Phase 1, Dose Escalation: TAK-981 75 mg QW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg BIW
n=8 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW on Days 1, 8, 15
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1, 8 and 15 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg BIW
n=8 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg QW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort A, NSCLC: TAK-981 90 mg BIW
Participants with non-squamous non-small cell lung cancer (NSCLC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort B, Cervical Cancer: TAK-981 90 mg BIW
Participants with cervical cancer received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 3 mg BIW
n=5 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 3 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 6 mg BIW
n=3 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 6 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 10 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 10 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 15 mg BIW
n=3 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 15 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 25 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 25 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 40 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 40 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg BIW
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg QW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 75 mg BIW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort C, MSS-CRC: TAK-981 90 mg BIW
Participants with microsatellite-stable colorectal cancer (MSS-CRC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort D, DLBCL After CAR T-cells Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) progressed or relapsed after chimeric antigen receptor (CAR) T-cell therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort E, DLBCL Without Prior Cellular Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory DLBCL that have not received prior cellular therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort F, Follicular Lymphoma: TAK-981 90 mg BIW
Participants with relapsed/refractory follicular lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Number of Participants With Grade 3 or Higher TEAEs
|
0 Participants
|
6 Participants
|
5 Participants
|
4 Participants
|
7 Participants
|
3 Participants
|
—
|
—
|
2 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From the first dose of study drug through 30 days after the last dose of study drug (up to 35.3 months)Population: Safety analysis set consisted of participants who received at least 1 dose, even if incomplete, of study drug.
TEAEs were AEs that occurred after administration of the first dose of any study drug and through 30 days after the last dose of any 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.
Outcome measures
| Measure |
Phase 1, Dose Escalation: TAK-981 75 mg QW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg BIW
n=8 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW on Days 1, 8, 15
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1, 8 and 15 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg BIW
n=8 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg QW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort A, NSCLC: TAK-981 90 mg BIW
Participants with non-squamous non-small cell lung cancer (NSCLC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort B, Cervical Cancer: TAK-981 90 mg BIW
Participants with cervical cancer received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 3 mg BIW
n=5 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 3 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 6 mg BIW
n=3 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 6 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 10 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 10 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 15 mg BIW
n=3 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 15 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 25 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 25 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 40 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 40 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg BIW
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg QW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 75 mg BIW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort C, MSS-CRC: TAK-981 90 mg BIW
Participants with microsatellite-stable colorectal cancer (MSS-CRC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort D, DLBCL After CAR T-cells Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) progressed or relapsed after chimeric antigen receptor (CAR) T-cell therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort E, DLBCL Without Prior Cellular Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory DLBCL that have not received prior cellular therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort F, Follicular Lymphoma: TAK-981 90 mg BIW
Participants with relapsed/refractory follicular lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Duration of TEAEs
|
2.0 days
Interval 1.0 to 58.0
|
4.5 days
Interval 1.0 to 188.0
|
5.0 days
Interval 1.0 to 37.0
|
2.0 days
Interval 1.0 to 80.0
|
3.0 days
Interval 1.0 to 131.0
|
4.0 days
Interval 1.0 to 64.0
|
—
|
—
|
3.0 days
Interval 1.0 to 37.0
|
4.0 days
Interval 1.0 to 21.0
|
1.0 days
Interval 1.0 to 33.0
|
3.0 days
Interval 1.0 to 5.0
|
4.0 days
Interval 1.0 to 39.0
|
9.5 days
Interval 1.0 to 36.0
|
4.0 days
Interval 1.0 to 42.0
|
3.0 days
Interval 1.0 to 47.0
|
8.0 days
Interval 1.0 to 82.0
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Cycle 1 (Cycle length is equal to [=] 21 days)Population: DLT-evaluable analysis set consisted of participants in dose escalation who received all Cycle 1 doses of TAK-981 without experiencing a DLT or who had a DLT during Cycle 1 of the study.
DLTs were evaluated according to NCI CTCAE version 5.0. Grade 5 AE. Hematologic toxicity: Nonfebrile Grade 4 neutropenia/Grade greater than or equal to (\>=) 3 febrile neutropenia; Significant Grade 3 thrombocytopenia; Grade 4 thrombocytopenia. Nonhematologic Grade 3 or higher toxicities; Grade 2 nonhematologic toxicities that were considered by the investigator to be related to study drug and dose-limiting.
Outcome measures
| Measure |
Phase 1, Dose Escalation: TAK-981 75 mg QW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg BIW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW on Days 1, 8, 15
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1, 8 and 15 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg BIW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg QW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort A, NSCLC: TAK-981 90 mg BIW
Participants with non-squamous non-small cell lung cancer (NSCLC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort B, Cervical Cancer: TAK-981 90 mg BIW
Participants with cervical cancer received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 3 mg BIW
n=3 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 3 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 6 mg BIW
n=3 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 6 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 10 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 10 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 15 mg BIW
n=3 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 15 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 25 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 25 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 40 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 40 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg BIW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg QW
n=5 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 75 mg BIW
n=5 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort C, MSS-CRC: TAK-981 90 mg BIW
Participants with microsatellite-stable colorectal cancer (MSS-CRC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort D, DLBCL After CAR T-cells Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) progressed or relapsed after chimeric antigen receptor (CAR) T-cell therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort E, DLBCL Without Prior Cellular Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory DLBCL that have not received prior cellular therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort F, Follicular Lymphoma: TAK-981 90 mg BIW
Participants with relapsed/refractory follicular lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From the first dose of study drug until first disease progression (PD) or death, whichever occurred first (up to 11.2 months)Population: Tumor response-evaluable analysis set consisted of participants who received at least 1 dose of study drug, had sites of measurable disease at baseline, and 1 postbaseline disease assessment, or was discontinued due to symptomatic deterioration or death before a postbaseline evaluation happened.
ORR was defined as percentage of participants who achieved complete response (CR) or partial response (PR) during the study as determined by the investigator according to response assessments based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST V1.1) for solid tumors or Lugano classification for lymphoma.
Outcome measures
| Measure |
Phase 1, Dose Escalation: TAK-981 75 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW on Days 1, 8, 15
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1, 8 and 15 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort A, NSCLC: TAK-981 90 mg BIW
Participants with non-squamous non-small cell lung cancer (NSCLC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort B, Cervical Cancer: TAK-981 90 mg BIW
Participants with cervical cancer received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 3 mg BIW
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 3 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 6 mg BIW
n=3 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 6 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 10 mg BIW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 10 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 15 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 15 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 25 mg BIW
n=3 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 25 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 40 mg BIW
n=1 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 40 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 75 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort C, MSS-CRC: TAK-981 90 mg BIW
Participants with microsatellite-stable colorectal cancer (MSS-CRC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort D, DLBCL After CAR T-cells Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) progressed or relapsed after chimeric antigen receptor (CAR) T-cell therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort E, DLBCL Without Prior Cellular Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory DLBCL that have not received prior cellular therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort F, Follicular Lymphoma: TAK-981 90 mg BIW
Participants with relapsed/refractory follicular lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Overall Response Rate (ORR)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.0 percentage of participants
Interval 0.0 to 40.96
|
0.0 percentage of participants
Interval 0.0 to 70.76
|
0.0 percentage of participants
Interval 0.0 to 45.93
|
0.0 percentage of participants
Interval 0.0 to 60.24
|
0.0 percentage of participants
Interval 0.0 to 70.76
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose; Cycle 1 Day 8: pre-dose and at multiple timepoints (up to 24 hours) post-dose (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. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specified time-points. As planned, this outcome measure was analyzed in Phase 1 only.
Cmax for TAK-981 was reported.
Outcome measures
| Measure |
Phase 1, Dose Escalation: TAK-981 75 mg QW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg BIW
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW on Days 1, 8, 15
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1, 8 and 15 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg BIW
n=8 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg QW
n=5 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort A, NSCLC: TAK-981 90 mg BIW
Participants with non-squamous non-small cell lung cancer (NSCLC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort B, Cervical Cancer: TAK-981 90 mg BIW
Participants with cervical cancer received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 3 mg BIW
n=5 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 3 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 6 mg BIW
n=3 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 6 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 10 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 10 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 15 mg BIW
n=3 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 15 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 25 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 25 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 40 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 40 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg BIW
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg QW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 75 mg BIW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort C, MSS-CRC: TAK-981 90 mg BIW
Participants with microsatellite-stable colorectal cancer (MSS-CRC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort D, DLBCL After CAR T-cells Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) progressed or relapsed after chimeric antigen receptor (CAR) T-cell therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort E, DLBCL Without Prior Cellular Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory DLBCL that have not received prior cellular therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort F, Follicular Lymphoma: TAK-981 90 mg BIW
Participants with relapsed/refractory follicular lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1, Cmax: Maximum Observed Plasma Concentration for TAK-981
Cycle 1 Day 1
|
685 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 30.4
|
773 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 49.3
|
887 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 54.5
|
668 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 32.9
|
1410 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 46.8
|
1100 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 36.4
|
—
|
—
|
14.0 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 74.6
|
22.5 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 19.7
|
46.1 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 45.3
|
61.0 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 69.0
|
124 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 80.9
|
314 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 37.8
|
417 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 33.4
|
446 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 27.4
|
738 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 37.1
|
—
|
—
|
—
|
—
|
|
Phase 1, Cmax: Maximum Observed Plasma Concentration for TAK-981
Cycle 1 Day 8
|
923 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 69.0
|
654 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 57.5
|
852 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 66.2
|
653 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 69.6
|
1460 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 65.7
|
825 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 22.3
|
—
|
—
|
—
|
22.5 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 22.8
|
33.8 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 35.7
|
114 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 103.6
|
108 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 39.2
|
428 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 49.9
|
343 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 26.6
|
405 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 35.6
|
846 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 33.3
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose; Cycle 1 Day 8: pre-dose and at multiple timepoints (up to 24 hours) post-dose (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. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specified time-points. As planned, this outcome measure was analyzed in Phase 1 only.
Tmax for TAK-981 was reported.
Outcome measures
| Measure |
Phase 1, Dose Escalation: TAK-981 75 mg QW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg BIW
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW on Days 1, 8, 15
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1, 8 and 15 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg BIW
n=8 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg QW
n=5 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort A, NSCLC: TAK-981 90 mg BIW
Participants with non-squamous non-small cell lung cancer (NSCLC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort B, Cervical Cancer: TAK-981 90 mg BIW
Participants with cervical cancer received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 3 mg BIW
n=5 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 3 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 6 mg BIW
n=3 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 6 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 10 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 10 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 15 mg BIW
n=3 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 15 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 25 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 25 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 40 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 40 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg BIW
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg QW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 75 mg BIW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort C, MSS-CRC: TAK-981 90 mg BIW
Participants with microsatellite-stable colorectal cancer (MSS-CRC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort D, DLBCL After CAR T-cells Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) progressed or relapsed after chimeric antigen receptor (CAR) T-cell therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort E, DLBCL Without Prior Cellular Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory DLBCL that have not received prior cellular therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort F, Follicular Lymphoma: TAK-981 90 mg BIW
Participants with relapsed/refractory follicular lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1, Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for TAK-981
Cycle 1 Day 1
|
1.17 hours
Interval 1.08 to 1.22
|
1.03 hours
Interval 1.0 to 1.13
|
1.12 hours
Interval 1.05 to 1.25
|
1.17 hours
Interval 1.03 to 1.25
|
1.11 hours
Interval 1.07 to 1.27
|
1.05 hours
Interval 1.02 to 1.17
|
—
|
—
|
1.17 hours
Interval 1.08 to 1.62
|
1.22 hours
Interval 1.03 to 1.33
|
1.03 hours
Interval 0.93 to 1.08
|
1.08 hours
Interval 1.07 to 1.65
|
1.08 hours
Interval 1.07 to 1.57
|
1.18 hours
Interval 1.05 to 2.13
|
1.12 hours
Interval 1.0 to 1.68
|
1.08 hours
Interval 1.0 to 1.4
|
1.02 hours
Interval 0.97 to 1.2
|
—
|
—
|
—
|
—
|
|
Phase 1, Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for TAK-981
Cycle 1 Day 8
|
1.05 hours
Interval 0.95 to 1.35
|
1.03 hours
Interval 1.0 to 1.12
|
1.12 hours
Interval 1.1 to 1.75
|
1.15 hours
Interval 0.98 to 3.08
|
1.08 hours
Interval 1.0 to 1.22
|
1.13 hours
Interval 1.08 to 1.17
|
—
|
—
|
—
|
1.19 hours
Interval 1.13 to 1.25
|
1.17 hours
Interval 1.07 to 2.08
|
1.03 hours
Interval 1.0 to 1.05
|
1.10 hours
Interval 1.03 to 1.42
|
1.09 hours
Interval 1.0 to 1.23
|
1.09 hours
Interval 1.03 to 1.13
|
1.13 hours
Interval 1.0 to 1.25
|
1.05 hours
Interval 1.0 to 1.17
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose; Cycle 1 Day 8: pre-dose and at multiple timepoints (up to 24 hours) post-dose (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. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specified time-points. As planned, this outcome measure was analyzed in Phase 1 only.
AUC0-last for TAK-981 was reported.
Outcome measures
| Measure |
Phase 1, Dose Escalation: TAK-981 75 mg QW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg BIW
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW on Days 1, 8, 15
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1, 8 and 15 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg BIW
n=8 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg QW
n=5 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort A, NSCLC: TAK-981 90 mg BIW
Participants with non-squamous non-small cell lung cancer (NSCLC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort B, Cervical Cancer: TAK-981 90 mg BIW
Participants with cervical cancer received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 3 mg BIW
n=5 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 3 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 6 mg BIW
n=3 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 6 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 10 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 10 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 15 mg BIW
n=3 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 15 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 25 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 25 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 40 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 40 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg BIW
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg QW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 75 mg BIW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort C, MSS-CRC: TAK-981 90 mg BIW
Participants with microsatellite-stable colorectal cancer (MSS-CRC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort D, DLBCL After CAR T-cells Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) progressed or relapsed after chimeric antigen receptor (CAR) T-cell therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort E, DLBCL Without Prior Cellular Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory DLBCL that have not received prior cellular therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort F, Follicular Lymphoma: TAK-981 90 mg BIW
Participants with relapsed/refractory follicular lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1, AUC0-last: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-981
Cycle 1 Day 1
|
1330 hours*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 15.7
|
1460 hours*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 31.0
|
1670 hours*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 31.9
|
1410 hours*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 31.8
|
2510 hours*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 30.1
|
1890 hours*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 39.7
|
—
|
—
|
50.1 hours*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 35.0
|
98.4 hours*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 15.5
|
178 hours*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 19.6
|
289 hours*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 40.6
|
438 hours*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 34.5
|
939 hours*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 20.7
|
1070 hours*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 28.2
|
1020 hours*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 25.8
|
1310 hours*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 16.9
|
—
|
—
|
—
|
—
|
|
Phase 1, AUC0-last: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-981
Cycle 1 Day 8
|
1310 hours*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 33.0
|
1230 hours*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 31.1
|
1650 hours*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 47.6
|
1300 hours*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 59.2
|
3050 hours*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 81.2
|
1620 hours*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 23.4
|
—
|
—
|
—
|
98.6 hours*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 13.5
|
174 hours*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 23.0
|
364 hours*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 58.0
|
405 hours*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 20.3
|
1020 hours*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 31.1
|
906 hours*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 30.6
|
931 hours*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 19.5
|
1220 hours*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 19.1
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose; Cycle 1 Day 8: pre-dose and at multiple timepoints (up to 24 hours) post-dose (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. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specified time-points. As planned, this outcome measure was analyzed in Phase 1 only.
AUC0-inf for TAK-981 was reported.
Outcome measures
| Measure |
Phase 1, Dose Escalation: TAK-981 75 mg QW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg BIW
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW on Days 1, 8, 15
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1, 8 and 15 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg BIW
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg QW
n=5 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort A, NSCLC: TAK-981 90 mg BIW
Participants with non-squamous non-small cell lung cancer (NSCLC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort B, Cervical Cancer: TAK-981 90 mg BIW
Participants with cervical cancer received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 3 mg BIW
n=5 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 3 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 6 mg BIW
n=3 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 6 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 10 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 10 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 15 mg BIW
n=3 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 15 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 25 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 25 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 40 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 40 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg BIW
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg QW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 75 mg BIW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort C, MSS-CRC: TAK-981 90 mg BIW
Participants with microsatellite-stable colorectal cancer (MSS-CRC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort D, DLBCL After CAR T-cells Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) progressed or relapsed after chimeric antigen receptor (CAR) T-cell therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort E, DLBCL Without Prior Cellular Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory DLBCL that have not received prior cellular therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort F, Follicular Lymphoma: TAK-981 90 mg BIW
Participants with relapsed/refractory follicular lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1, AUC0-inf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-981
Cycle 1 Day 1
|
1350 h*ng/mL
Geometric Coefficient of Variation 15.5
|
1480 h*ng/mL
Geometric Coefficient of Variation 31.6
|
1700 h*ng/mL
Geometric Coefficient of Variation 31.7
|
1360 h*ng/mL
Geometric Coefficient of Variation 32.3
|
2540 h*ng/mL
Geometric Coefficient of Variation 33.3
|
2280 h*ng/mL
Geometric Coefficient of Variation 5.6
|
—
|
—
|
53.5 h*ng/mL
Geometric Coefficient of Variation 31.1
|
100 h*ng/mL
Geometric Coefficient of Variation 14.7
|
181 h*ng/mL
Geometric Coefficient of Variation 19.5
|
294 h*ng/mL
Geometric Coefficient of Variation 39.2
|
443 h*ng/mL
Geometric Coefficient of Variation 34.7
|
949 h*ng/mL
Geometric Coefficient of Variation 20.2
|
1090 h*ng/mL
Geometric Coefficient of Variation 28.0
|
1040 h*ng/mL
Geometric Coefficient of Variation 26.1
|
1330 h*ng/mL
Geometric Coefficient of Variation 17.0
|
—
|
—
|
—
|
—
|
|
Phase 1, AUC0-inf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-981
Cycle 1 Day 8
|
1410 h*ng/mL
Geometric Coefficient of Variation 31.4
|
1310 h*ng/mL
Geometric Coefficient of Variation 28.3
|
1710 h*ng/mL
Geometric Coefficient of Variation 46.8
|
1190 h*ng/mL
Geometric Coefficient of Variation 40.8
|
2590 h*ng/mL
Geometric Coefficient of Variation 60.2
|
1710 h*ng/mL
Geometric Coefficient of Variation 24.4
|
—
|
—
|
—
|
103 h*ng/mL
Geometric Coefficient of Variation 12.8
|
183 h*ng/mL
Geometric Coefficient of Variation 21.9
|
382 h*ng/mL
Geometric Coefficient of Variation 53.5
|
438 h*ng/mL
Geometric Coefficient of Variation 16.2
|
1050 h*ng/mL
Geometric Coefficient of Variation 29.9
|
897 h*ng/mL
Geometric Coefficient of Variation 30.7
|
967 h*ng/mL
Geometric Coefficient of Variation 20.6
|
1260 h*ng/mL
Geometric Coefficient of Variation 21.9
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose; Cycle 1 Day 8: pre-dose and at multiple timepoints (up to 24 hours) post-dose (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. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specified time-points. As planned, this outcome measure was analyzed in Phase 1 only.
t1/2z for TAK-981 was reported.
Outcome measures
| Measure |
Phase 1, Dose Escalation: TAK-981 75 mg QW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg BIW
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW on Days 1, 8, 15
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1, 8 and 15 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg BIW
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg QW
n=5 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort A, NSCLC: TAK-981 90 mg BIW
Participants with non-squamous non-small cell lung cancer (NSCLC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort B, Cervical Cancer: TAK-981 90 mg BIW
Participants with cervical cancer received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 3 mg BIW
n=5 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 3 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 6 mg BIW
n=3 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 6 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 10 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 10 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 15 mg BIW
n=3 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 15 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 25 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 25 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 40 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 40 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg BIW
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg QW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 75 mg BIW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort C, MSS-CRC: TAK-981 90 mg BIW
Participants with microsatellite-stable colorectal cancer (MSS-CRC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort D, DLBCL After CAR T-cells Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) progressed or relapsed after chimeric antigen receptor (CAR) T-cell therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort E, DLBCL Without Prior Cellular Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory DLBCL that have not received prior cellular therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort F, Follicular Lymphoma: TAK-981 90 mg BIW
Participants with relapsed/refractory follicular lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1, t1/2z: Terminal Disposition Phase Half-life for TAK-981
Cycle 1 Day 1
|
9.62 hours
Interval 7.3 to 10.48
|
8.01 hours
Interval 5.39 to 9.9
|
8.32 hours
Interval 7.06 to 13.77
|
8.38 hours
Interval 7.01 to 10.74
|
8.99 hours
Interval 7.38 to 11.67
|
8.61 hours
Interval 7.01 to 9.74
|
—
|
—
|
5.41 hours
Interval 2.92 to 6.4
|
7.37 hours
Interval 4.9 to 9.9
|
7.60 hours
Interval 6.92 to 8.49
|
7.88 hours
Interval 5.81 to 10.32
|
7.87 hours
Interval 7.3 to 9.78
|
8.12 hours
Interval 6.77 to 9.19
|
9.18 hours
Interval 8.05 to 10.95
|
8.89 hours
Interval 6.56 to 11.81
|
9.44 hours
Interval 7.58 to 10.23
|
—
|
—
|
—
|
—
|
|
Phase 1, t1/2z: Terminal Disposition Phase Half-life for TAK-981
Cycle 1 Day 8
|
2.95 hours
Interval 2.32 to 7.3
|
5.45 hours
Interval 3.02 to 6.13
|
6.54 hours
Interval 5.4 to 7.02
|
5.43 hours
Interval 3.0 to 6.2
|
6.20 hours
Interval 6.03 to 16.02
|
6.36 hours
Interval 3.12 to 7.16
|
—
|
—
|
—
|
5.74 hours
Interval 5.65 to 5.83
|
6.02 hours
Interval 4.53 to 6.74
|
6.08 hours
Interval 4.51 to 7.45
|
6.38 hours
Interval 6.12 to 10.33
|
5.73 hours
Interval 5.03 to 6.14
|
6.47 hours
Interval 5.15 to 6.59
|
6.16 hours
Interval 5.26 to 7.36
|
4.64 hours
Interval 3.12 to 6.81
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose; Cycle 1 Day 8: pre-dose and at multiple timepoints (up to 24 hours) post-dose (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. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specified time-points. As planned, this outcome measure was analyzed in Phase 1 only.
CL for TAK-981 was reported.
Outcome measures
| Measure |
Phase 1, Dose Escalation: TAK-981 75 mg QW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg BIW
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW on Days 1, 8, 15
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1, 8 and 15 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg BIW
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg QW
n=5 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort A, NSCLC: TAK-981 90 mg BIW
Participants with non-squamous non-small cell lung cancer (NSCLC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort B, Cervical Cancer: TAK-981 90 mg BIW
Participants with cervical cancer received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 3 mg BIW
n=5 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 3 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 6 mg BIW
n=3 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 6 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 10 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 10 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 15 mg BIW
n=3 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 15 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 25 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 25 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 40 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 40 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg BIW
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg QW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 75 mg BIW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort C, MSS-CRC: TAK-981 90 mg BIW
Participants with microsatellite-stable colorectal cancer (MSS-CRC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort D, DLBCL After CAR T-cells Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) progressed or relapsed after chimeric antigen receptor (CAR) T-cell therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort E, DLBCL Without Prior Cellular Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory DLBCL that have not received prior cellular therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort F, Follicular Lymphoma: TAK-981 90 mg BIW
Participants with relapsed/refractory follicular lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1, CL: Total Clearance for TAK-981
Cycle 1 Day 1
|
55.7 liter per hour (L/h)
Geometric Coefficient of Variation 15.5
|
60.7 liter per hour (L/h)
Geometric Coefficient of Variation 31.6
|
52.9 liter per hour (L/h)
Geometric Coefficient of Variation 31.7
|
66.0 liter per hour (L/h)
Geometric Coefficient of Variation 32.3
|
47.3 liter per hour (L/h)
Geometric Coefficient of Variation 33.3
|
52.6 liter per hour (L/h)
Geometric Coefficient of Variation 5.6
|
—
|
—
|
56.1 liter per hour (L/h)
Geometric Coefficient of Variation 31.1
|
59.8 liter per hour (L/h)
Geometric Coefficient of Variation 14.7
|
55.3 liter per hour (L/h)
Geometric Coefficient of Variation 19.5
|
51.0 liter per hour (L/h)
Geometric Coefficient of Variation 39.2
|
56.4 liter per hour (L/h)
Geometric Coefficient of Variation 34.7
|
42.2 liter per hour (L/h)
Geometric Coefficient of Variation 20.2
|
55.3 liter per hour (L/h)
Geometric Coefficient of Variation 28.0
|
57.8 liter per hour (L/h)
Geometric Coefficient of Variation 26.1
|
56.3 liter per hour (L/h)
Geometric Coefficient of Variation 17.0
|
—
|
—
|
—
|
—
|
|
Phase 1, CL: Total Clearance for TAK-981
Cycle 1 Day 8
|
53.1 liter per hour (L/h)
Geometric Coefficient of Variation 31.4
|
68.8 liter per hour (L/h)
Geometric Coefficient of Variation 28.3
|
52.8 liter per hour (L/h)
Geometric Coefficient of Variation 46.8
|
75.6 liter per hour (L/h)
Geometric Coefficient of Variation 40.8
|
46.4 liter per hour (L/h)
Geometric Coefficient of Variation 60.2
|
70.3 liter per hour (L/h)
Geometric Coefficient of Variation 24.4
|
—
|
—
|
—
|
58.3 liter per hour (L/h)
Geometric Coefficient of Variation 12.8
|
54.7 liter per hour (L/h)
Geometric Coefficient of Variation 21.9
|
39.3 liter per hour (L/h)
Geometric Coefficient of Variation 53.5
|
57.1 liter per hour (L/h)
Geometric Coefficient of Variation 16.2
|
38.1 liter per hour (L/h)
Geometric Coefficient of Variation 29.9
|
66.9 liter per hour (L/h)
Geometric Coefficient of Variation 30.7
|
62.0 liter per hour (L/h)
Geometric Coefficient of Variation 20.6
|
59.4 liter per hour (L/h)
Geometric Coefficient of Variation 21.9
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose; Cycle 1 Day 8: pre-dose and at multiple timepoints (up to 24 hours) post-dose (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. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specified time-points. As planned, this outcome measure was analyzed in Phase 1 only.
Vss for TAK-981 was reported.
Outcome measures
| Measure |
Phase 1, Dose Escalation: TAK-981 75 mg QW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg BIW
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW on Days 1, 8, 15
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1, 8 and 15 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg BIW
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg QW
n=5 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort A, NSCLC: TAK-981 90 mg BIW
Participants with non-squamous non-small cell lung cancer (NSCLC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort B, Cervical Cancer: TAK-981 90 mg BIW
Participants with cervical cancer received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 3 mg BIW
n=5 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 3 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 6 mg BIW
n=3 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 6 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 10 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 10 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 15 mg BIW
n=3 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 15 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 25 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 25 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 40 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 40 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg BIW
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg QW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 75 mg BIW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort C, MSS-CRC: TAK-981 90 mg BIW
Participants with microsatellite-stable colorectal cancer (MSS-CRC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort D, DLBCL After CAR T-cells Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) progressed or relapsed after chimeric antigen receptor (CAR) T-cell therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort E, DLBCL Without Prior Cellular Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory DLBCL that have not received prior cellular therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort F, Follicular Lymphoma: TAK-981 90 mg BIW
Participants with relapsed/refractory follicular lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1, Vss: Volume of Distribution at Steady State for TAK-981
Cycle 1 Day 8
|
144 liters
Geometric Coefficient of Variation 84.8
|
285 liters
Geometric Coefficient of Variation 39.3
|
241 liters
Geometric Coefficient of Variation 76.2
|
307 liters
Geometric Coefficient of Variation 60.6
|
255 liters
Geometric Coefficient of Variation 36.6
|
322 liters
Geometric Coefficient of Variation 32.7
|
—
|
—
|
—
|
385 liters
Geometric Coefficient of Variation 12.9
|
390 liters
Geometric Coefficient of Variation 32.0
|
233 liters
Geometric Coefficient of Variation 119.7
|
441 liters
Geometric Coefficient of Variation 41.0
|
173 liters
Geometric Coefficient of Variation 51.7
|
400 liters
Geometric Coefficient of Variation 32.2
|
334 liters
Geometric Coefficient of Variation 21.2
|
185 liters
Geometric Coefficient of Variation 48.8
|
—
|
—
|
—
|
—
|
|
Phase 1, Vss: Volume of Distribution at Steady State for TAK-981
Cycle 1 Day 1
|
345 liters
Geometric Coefficient of Variation 29.1
|
314 liters
Geometric Coefficient of Variation 46.3
|
290 liters
Geometric Coefficient of Variation 59.4
|
396 liters
Geometric Coefficient of Variation 25.8
|
271 liters
Geometric Coefficient of Variation 31.3
|
288 liters
Geometric Coefficient of Variation 27.6
|
—
|
—
|
332 liters
Geometric Coefficient of Variation 37.9
|
437 liters
Geometric Coefficient of Variation 18.2
|
443 liters
Geometric Coefficient of Variation 28.9
|
411 liters
Geometric Coefficient of Variation 72.8
|
392 liters
Geometric Coefficient of Variation 39.9
|
234 liters
Geometric Coefficient of Variation 36.0
|
359 liters
Geometric Coefficient of Variation 33.5
|
367 liters
Geometric Coefficient of Variation 19.2
|
311 liters
Geometric Coefficient of Variation 24.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the first dose of study drug until first PD or death, whichever occurred first (up to 34.3 months)Population: Tumor response-evaluable analysis set consisted of participants who received at least 1 dose of study drug, had sites of measurable disease at baseline, and 1 postbaseline disease assessment, or was discontinued due to symptomatic deterioration or death before a postbaseline evaluation happened.
ORR was defined as percentage of participants who achieved CR or PR during the study as determined by the investigator according to response assessments based on RECIST v1.1 for solid tumors or Lugano classification for lymphoma.
Outcome measures
| Measure |
Phase 1, Dose Escalation: TAK-981 75 mg QW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg BIW
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW on Days 1, 8, 15
n=5 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1, 8 and 15 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg BIW
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg QW
n=5 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort A, NSCLC: TAK-981 90 mg BIW
Participants with non-squamous non-small cell lung cancer (NSCLC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort B, Cervical Cancer: TAK-981 90 mg BIW
Participants with cervical cancer received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 3 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 3 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 6 mg BIW
n=3 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 6 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 10 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 10 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 15 mg BIW
n=3 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 15 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 25 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 25 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 40 mg BIW
n=3 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 40 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg BIW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg QW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 75 mg BIW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort C, MSS-CRC: TAK-981 90 mg BIW
Participants with microsatellite-stable colorectal cancer (MSS-CRC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort D, DLBCL After CAR T-cells Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) progressed or relapsed after chimeric antigen receptor (CAR) T-cell therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort E, DLBCL Without Prior Cellular Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory DLBCL that have not received prior cellular therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort F, Follicular Lymphoma: TAK-981 90 mg BIW
Participants with relapsed/refractory follicular lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: ORR
|
0.0 percentage of participants
Interval 0.0 to 45.93
|
0.0 percentage of participants
Interval 0.0 to 40.96
|
16.7 percentage of participants
Interval 0.42 to 64.12
|
0.0 percentage of participants
Interval 0.0 to 52.18
|
14.3 percentage of participants
Interval 0.36 to 57.87
|
0.0 percentage of participants
Interval 0.0 to 52.18
|
—
|
—
|
0.0 percentage of participants
Interval 0.0 to 60.24
|
0.0 percentage of participants
Interval 0.0 to 70.76
|
0.0 percentage of participants
Interval 0.0 to 60.24
|
0.0 percentage of participants
Interval 0.0 to 70.76
|
0.0 percentage of participants
Interval 0.0 to 60.24
|
33.3 percentage of participants
Interval 0.84 to 90.57
|
0.0 percentage of participants
Interval 0.0 to 45.93
|
0.0 percentage of participants
Interval 0.0 to 45.93
|
0.0 percentage of participants
Interval 0.0 to 45.93
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug up to 34.3 months (for Phase 1) and up to 11.2 months (for Phase 2)Population: Tumor response-evaluable analysis set consisted of participants who received at least 1 dose of study drug, had sites of measurable disease at baseline, and 1 postbaseline disease assessment, or was discontinued due to symptomatic deterioration or death before a postbaseline evaluation happened.
DCR was defined as the percentage of participants who achieved stable disease (SD) (greater than \[\>\] 6 weeks) or better as determined by the investigator according to RECIST v1.1 for solid tumors or Lugano classification for lymphoma.
Outcome measures
| Measure |
Phase 1, Dose Escalation: TAK-981 75 mg QW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg BIW
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW on Days 1, 8, 15
n=5 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1, 8 and 15 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg BIW
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg QW
n=5 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort A, NSCLC: TAK-981 90 mg BIW
n=7 Participants
Participants with non-squamous non-small cell lung cancer (NSCLC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort B, Cervical Cancer: TAK-981 90 mg BIW
n=3 Participants
Participants with cervical cancer received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 3 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 3 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 6 mg BIW
n=3 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 6 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 10 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 10 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 15 mg BIW
n=3 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 15 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 25 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 25 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 40 mg BIW
n=3 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 40 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg BIW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg QW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 75 mg BIW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort C, MSS-CRC: TAK-981 90 mg BIW
n=6 Participants
Participants with microsatellite-stable colorectal cancer (MSS-CRC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort D, DLBCL After CAR T-cells Therapy: TAK-981 90 mg BIW
n=4 Participants
Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) progressed or relapsed after chimeric antigen receptor (CAR) T-cell therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort E, DLBCL Without Prior Cellular Therapy: TAK-981 90 mg BIW
n=3 Participants
Participants with relapsed/refractory DLBCL that have not received prior cellular therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort F, Follicular Lymphoma: TAK-981 90 mg BIW
n=1 Participants
Participants with relapsed/refractory follicular lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1 and 2: Disease Control Rate (DCR)
|
66.7 percentage of participants
Interval 22.28 to 95.67
|
42.9 percentage of participants
Interval 9.9 to 81.59
|
50.0 percentage of participants
Interval 11.81 to 88.19
|
60.0 percentage of participants
Interval 14.66 to 94.73
|
42.9 percentage of participants
Interval 9.9 to 81.59
|
20.0 percentage of participants
Interval 0.51 to 71.64
|
71.4 percentage of participants
Interval 29.04 to 96.33
|
66.7 percentage of participants
Interval 9.43 to 99.16
|
0.0 percentage of participants
Interval 0.0 to 60.24
|
0.0 percentage of participants
Interval 0.0 to 70.76
|
25.0 percentage of participants
Interval 0.63 to 80.59
|
33.3 percentage of participants
Interval 0.84 to 90.57
|
75.0 percentage of participants
Interval 19.41 to 99.37
|
66.7 percentage of participants
Interval 9.43 to 99.16
|
0.0 percentage of participants
Interval 0.0 to 45.93
|
66.7 percentage of participants
Interval 22.28 to 95.67
|
16.7 percentage of participants
Interval 0.42 to 64.12
|
33.3 percentage of participants
Interval 4.33 to 77.72
|
0.0 percentage of participants
Interval 0.0 to 60.24
|
0.0 percentage of participants
Interval 0.0 to 70.76
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
SECONDARY outcome
Timeframe: From first documented confirmed CR or PR until first documentation of PD up to 34.3 months (for Phase 1) and up to 11.2 months (for Phase 2)Population: Tumor response-evaluable analysis set consisted of participants who received at least 1 dose of study drug, had sites of measurable disease at baseline, and 1 postbaseline disease assessment, or was discontinued due to symptomatic deterioration or death before a postbaseline evaluation happened. Here, "overall number of participants analyzed" signifies participants who had CR or PR.
DOR was defined as 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) and determined by the investigator according to RECIST v1.1 with solid tumors or Lugano classification for lymphoma.
Outcome measures
| Measure |
Phase 1, Dose Escalation: TAK-981 75 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW
n=1 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW on Days 1, 8, 15
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1, 8 and 15 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg BIW
n=1 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort A, NSCLC: TAK-981 90 mg BIW
Participants with non-squamous non-small cell lung cancer (NSCLC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort B, Cervical Cancer: TAK-981 90 mg BIW
Participants with cervical cancer received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 3 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 3 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 6 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 6 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 10 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 10 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 15 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 15 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 25 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 25 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 40 mg BIW
n=1 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 40 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 75 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort C, MSS-CRC: TAK-981 90 mg BIW
Participants with microsatellite-stable colorectal cancer (MSS-CRC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort D, DLBCL After CAR T-cells Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) progressed or relapsed after chimeric antigen receptor (CAR) T-cell therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort E, DLBCL Without Prior Cellular Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory DLBCL that have not received prior cellular therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort F, Follicular Lymphoma: TAK-981 90 mg BIW
n=1 Participants
Participants with relapsed/refractory follicular lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1 and 2: Duration of Response (DOR)
|
—
|
—
|
1.41 months
Upper and lower limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
—
|
NA months
Median, upper and lower limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
6.93 months
Upper and lower limit of 95% confidence internal (CI) could not be estimated due to insufficient number of participants with events.
|
—
|
—
|
—
|
—
|
—
|
—
|
5.55 months
Upper and lower limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: From first dose of study drug to the date of the first documentation of PD up to 34.3 months (for Phase 1) and up to 11.2 months (for Phase 2)Population: Tumor response-evaluable analysis set consisted of participants who received at least 1 dose of study drug, had sites of measurable disease at baseline, and 1 postbaseline disease assessment, or was discontinued due to symptomatic deterioration or death before a postbaseline evaluation happened.
TTP was defined as the time from the date of the first dose administration to the date of first documented PD as determined by the investigator according to RECIST v1.1 for solid tumors or Lugano classification for lymphoma.
Outcome measures
| Measure |
Phase 1, Dose Escalation: TAK-981 75 mg QW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg BIW
n=8 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW on Days 1, 8, 15
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1, 8 and 15 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg BIW
n=8 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg QW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort A, NSCLC: TAK-981 90 mg BIW
n=7 Participants
Participants with non-squamous non-small cell lung cancer (NSCLC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort B, Cervical Cancer: TAK-981 90 mg BIW
n=3 Participants
Participants with cervical cancer received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 3 mg BIW
n=5 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 3 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 6 mg BIW
n=3 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 6 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 10 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 10 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 15 mg BIW
n=3 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 15 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 25 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 25 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 40 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 40 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg BIW
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg QW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 75 mg BIW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort C, MSS-CRC: TAK-981 90 mg BIW
n=7 Participants
Participants with microsatellite-stable colorectal cancer (MSS-CRC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort D, DLBCL After CAR T-cells Therapy: TAK-981 90 mg BIW
n=4 Participants
Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) progressed or relapsed after chimeric antigen receptor (CAR) T-cell therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort E, DLBCL Without Prior Cellular Therapy: TAK-981 90 mg BIW
n=3 Participants
Participants with relapsed/refractory DLBCL that have not received prior cellular therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort F, Follicular Lymphoma: TAK-981 90 mg BIW
n=1 Participants
Participants with relapsed/refractory follicular lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1 and 2: Time to Progression (TTP)
|
2.71 months
Interval 1.35 to 8.08
|
6.97 months
Interval 2.66 to
Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
3.94 months
Interval 1.18 to
Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
2.79 months
Interval 1.25 to
Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
NA months
Interval 1.38 to
Median and upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
1.97 months
Interval 1.74 to 2.04
|
6.06 months
Interval 2.07 to
Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
3.78 months
Interval 0.99 to
Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
1.18 months
Interval 0.72 to
Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
0.79 months
Interval 0.76 to
Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
1.38 months
Interval 0.59 to
Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
1.25 months
Interval 1.18 to
Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
2.10 months
Interval 1.38 to
Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
5.49 months
Interval 1.25 to
Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
1.21 months
Interval 0.46 to
Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
3.75 months
Interval 0.72 to
Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
1.28 months
Interval 1.22 to
Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
1.18 months
Interval 0.92 to
Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
1.04 months
Interval 0.59 to
Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
1.09 months
Interval 0.43 to
Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
11.17 months
Upper and lower limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: From first dose of study drug to the date of the first documentation of PR or better, whichever occurred first up to 34.3 months (for Phase 1) and up to 11.2 months (for Phase 2)Population: Tumor response-evaluable analysis set consisted of participants who received at least 1 dose of study drug, had sites of measurable disease at baseline, and 1 postbaseline disease assessment, or was discontinued due to symptomatic deterioration or death before a postbaseline evaluation happened.
TTR was defined as the time from the date of first study drug administration to the date of first documented PR or better by the investigator for responders according to RECIST v1.1 for solid tumors or Lugano classification for lymphoma. Here, "overall number of participants analyzed" signifies participants who had CR or PR.
Outcome measures
| Measure |
Phase 1, Dose Escalation: TAK-981 75 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW
n=1 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW on Days 1, 8, 15
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1, 8 and 15 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg BIW
n=1 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort A, NSCLC: TAK-981 90 mg BIW
Participants with non-squamous non-small cell lung cancer (NSCLC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort B, Cervical Cancer: TAK-981 90 mg BIW
Participants with cervical cancer received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 3 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 3 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 6 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 6 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 10 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 10 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 15 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 15 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 25 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 25 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 40 mg BIW
n=1 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 40 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 75 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort C, MSS-CRC: TAK-981 90 mg BIW
Participants with microsatellite-stable colorectal cancer (MSS-CRC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort D, DLBCL After CAR T-cells Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) progressed or relapsed after chimeric antigen receptor (CAR) T-cell therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort E, DLBCL Without Prior Cellular Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory DLBCL that have not received prior cellular therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort F, Follicular Lymphoma: TAK-981 90 mg BIW
n=1 Participants
Participants with relapsed/refractory follicular lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1 and 2: Time to Response (TTR)
|
—
|
—
|
NA months
Interval 3.91 to
Median and upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
—
|
NA months
Interval 1.74 to
Median and upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
NA months
Interval 1.38 to
Median and upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
—
|
—
|
—
|
—
|
—
|
—
|
5.65 months
Upper limit and lower limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: From the first dose of study drug to date of PD or death, whichever occurred first up to 34.3 months (for Phase 1) and up to 11.2 months (for Phase 2)Population: Safety analysis set consisted of participants who received at least 1 dose, even if incomplete, of study drug.
PFS was 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 as determined by the investigator according to RECIST v1.1 for solid tumors or Lugano classification for lymphoma.
Outcome measures
| Measure |
Phase 1, Dose Escalation: TAK-981 75 mg QW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg BIW
n=8 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW on Days 1, 8, 15
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1, 8 and 15 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg BIW
n=8 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg QW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort A, NSCLC: TAK-981 90 mg BIW
n=7 Participants
Participants with non-squamous non-small cell lung cancer (NSCLC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort B, Cervical Cancer: TAK-981 90 mg BIW
n=3 Participants
Participants with cervical cancer received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 3 mg BIW
n=5 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 3 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 6 mg BIW
n=3 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 6 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 10 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 10 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 15 mg BIW
n=3 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 15 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 25 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 25 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 40 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 40 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg BIW
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg QW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 75 mg BIW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort C, MSS-CRC: TAK-981 90 mg BIW
n=7 Participants
Participants with microsatellite-stable colorectal cancer (MSS-CRC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort D, DLBCL After CAR T-cells Therapy: TAK-981 90 mg BIW
n=4 Participants
Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) progressed or relapsed after chimeric antigen receptor (CAR) T-cell therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort E, DLBCL Without Prior Cellular Therapy: TAK-981 90 mg BIW
n=3 Participants
Participants with relapsed/refractory DLBCL that have not received prior cellular therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort F, Follicular Lymphoma: TAK-981 90 mg BIW
n=1 Participants
Participants with relapsed/refractory follicular lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1 and 2: Progression-free Survival (PFS)
|
2.71 months
Interval 1.35 to 8.08
|
2.66 months
Interval 0.82 to
Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
3.94 months
Interval 1.18 to
Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
2.79 months
Interval 1.25 to
Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
3.32 months
Interval 1.38 to
Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
1.97 months
Interval 1.74 to 2.04
|
6.06 months
Interval 2.07 to
Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
3.78 months
Interval 0.99 to
Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
0.95 months
Interval 0.46 to
Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
0.79 months
Interval 0.76 to
Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
1.38 months
Interval 0.59 to
Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
1.25 months
Interval 1.18 to
Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
2.10 months
Interval 1.38 to
Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
5.49 months
Interval 1.25 to
Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
1.18 months
Interval 0.46 to
Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
2.53 months
Interval 1.02 to
Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
1.27 months
Interval 1.22 to 1.54
|
1.18 months
Interval 0.92 to
Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
1.38 months
Interval 0.59 to
Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
1.09 months
Interval 0.43 to
Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
11.17 months
Upper limit and lower limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: From date of first dose of study drug up to death up to 34.3 months (for Phase 1) and up to 11.2 months (for Phase 2)Population: Safety analysis set consisted of participants who received at least 1 dose, even if incomplete, of study drug.
OS was defined as the time from the date of the first dose administration to the date of death.
Outcome measures
| Measure |
Phase 1, Dose Escalation: TAK-981 75 mg QW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg BIW
n=8 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW on Days 1, 8, 15
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1, 8 and 15 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg BIW
n=8 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg QW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort A, NSCLC: TAK-981 90 mg BIW
n=7 Participants
Participants with non-squamous non-small cell lung cancer (NSCLC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort B, Cervical Cancer: TAK-981 90 mg BIW
n=3 Participants
Participants with cervical cancer received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 3 mg BIW
n=5 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 3 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 6 mg BIW
n=3 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 6 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 10 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 10 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 15 mg BIW
n=3 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 15 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 25 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 25 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 40 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 40 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg BIW
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg QW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 75 mg BIW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort C, MSS-CRC: TAK-981 90 mg BIW
n=7 Participants
Participants with microsatellite-stable colorectal cancer (MSS-CRC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort D, DLBCL After CAR T-cells Therapy: TAK-981 90 mg BIW
n=4 Participants
Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) progressed or relapsed after chimeric antigen receptor (CAR) T-cell therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort E, DLBCL Without Prior Cellular Therapy: TAK-981 90 mg BIW
n=3 Participants
Participants with relapsed/refractory DLBCL that have not received prior cellular therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort F, Follicular Lymphoma: TAK-981 90 mg BIW
n=1 Participants
Participants with relapsed/refractory follicular lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1 and 2: Overall Survival (OS)
|
NA months
Median, upper limit and lower limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
NA months
Interval 0.82 to
Median and upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
5.49 months
Interval 5.49 to
Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
NA months
Interval 1.77 to
Median and upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
NA months
Interval 5.22 to
Median and upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
NA months
Median, upper limit and lower limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
NA months
Interval 1.87 to
Median and upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
NA months
Interval 3.29 to
Median and upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
NA months
Interval 0.46 to
Median and upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
NA months
Median, upper limit and lower limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
NA months
Median, upper limit and lower limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
NA months
Median, upper limit and lower limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
NA months
Interval 3.02 to
Median and upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
NA months
Interval 1.48 to
Median and upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
NA months
Interval 1.25 to
Median and upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
NA months
Median, upper limit and lower limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
NA months
Median, upper limit and lower limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
NA months
Interval 1.87 to
Median and upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
2.43 months
Interval 1.28 to
Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
6.14 months
Interval 1.58 to
Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
NA months
Median, upper limit and lower limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1: 1, 4 and 8 hours post-dose; Cycle 1 Day 8: Pre-dose, 1, 4 and 8 hours post-dose (Cycle length = 21 days)Population: Pharmacodynamic analysis set consisted of participants who provided evaluable blood samples (Cycle 1 Day 1 pre-dose sample and at least 1 post-dose sample). Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and here, "number analyzed" signifies participants evaluable at specified time-points.
TAK-981-SUMO adduct formation in peripheral blood lymphocytes was tested by flow cytometry with an antibody recognizing the TAK-981-SUMO adduct formation during the inhibition of the SUMO-activating enzyme by TAK-981.
Outcome measures
| Measure |
Phase 1, Dose Escalation: TAK-981 75 mg QW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg BIW
n=8 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW on Days 1, 8, 15
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1, 8 and 15 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg BIW
n=8 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg QW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort A, NSCLC: TAK-981 90 mg BIW
Participants with non-squamous non-small cell lung cancer (NSCLC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort B, Cervical Cancer: TAK-981 90 mg BIW
Participants with cervical cancer received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 3 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 3 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 6 mg BIW
n=3 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 6 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 10 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 10 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 15 mg BIW
n=3 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 15 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 25 mg BIW
n=3 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 25 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 40 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 40 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg BIW
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg QW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 75 mg BIW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort C, MSS-CRC: TAK-981 90 mg BIW
Participants with microsatellite-stable colorectal cancer (MSS-CRC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort D, DLBCL After CAR T-cells Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) progressed or relapsed after chimeric antigen receptor (CAR) T-cell therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort E, DLBCL Without Prior Cellular Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory DLBCL that have not received prior cellular therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort F, Follicular Lymphoma: TAK-981 90 mg BIW
Participants with relapsed/refractory follicular lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Fold Change From Baseline in Levels of TAK-981 Small Ubiquitin-like Modifier (SUMO) Adduct Formation in Blood Lymphocytes
Cycle 1 Day 1: 4 hour post-dose
|
5.8 fold change
Standard Deviation 1.05
|
6.0 fold change
Standard Deviation 1.05
|
6.2 fold change
Standard Deviation 1.10
|
5.9 fold change
Standard Deviation 1.42
|
6.2 fold change
Standard Deviation 1.32
|
5.8 fold change
Standard Deviation 1.22
|
—
|
—
|
1.6 fold change
Standard Deviation 0.19
|
2.1 fold change
Standard Deviation 0.04
|
2.6 fold change
Standard Deviation 1.64
|
4.8 fold change
Standard Deviation 0.70
|
5.1 fold change
Standard Deviation 0.74
|
5.8 fold change
Standard Deviation 0.44
|
6.2 fold change
Standard Deviation 2.15
|
4.7 fold change
Standard Deviation 1.57
|
5.8 fold change
Standard Deviation 0.86
|
—
|
—
|
—
|
—
|
|
Phase 1: Fold Change From Baseline in Levels of TAK-981 Small Ubiquitin-like Modifier (SUMO) Adduct Formation in Blood Lymphocytes
Cycle 1 Day 1: 1 hour post-dose
|
7.0 fold change
Standard Deviation 2.03
|
8.5 fold change
Standard Deviation 1.10
|
8.8 fold change
Standard Deviation 1.46
|
8.1 fold change
Standard Deviation 2.12
|
8.5 fold change
Standard Deviation 2.12
|
8.1 fold change
Standard Deviation 1.41
|
—
|
—
|
1.8 fold change
Standard Deviation 0.21
|
2.3 fold change
Standard Deviation 0.16
|
2.9 fold change
Standard Deviation 1.38
|
5.9 fold change
Standard Deviation 0.83
|
5.9 fold change
Standard Deviation 1.07
|
8.4 fold change
Standard Deviation 1.25
|
7.5 fold change
Standard Deviation 2.57
|
6.5 fold change
Standard Deviation 2.27
|
7.8 fold change
Standard Deviation 1.59
|
—
|
—
|
—
|
—
|
|
Phase 1: Fold Change From Baseline in Levels of TAK-981 Small Ubiquitin-like Modifier (SUMO) Adduct Formation in Blood Lymphocytes
Cycle 1 Day 1: 8 hour post-dose
|
4.8 fold change
Standard Deviation 1.10
|
4.7 fold change
Standard Deviation 1.02
|
5.5 fold change
Standard Deviation 1.32
|
4.9 fold change
Standard Deviation 1.20
|
5.0 fold change
Standard Deviation 0.94
|
4.0 fold change
Standard Deviation 1.21
|
—
|
—
|
1.5 fold change
Standard Deviation 0.23
|
1.9 fold change
Standard Deviation 0.08
|
2.7 fold change
Standard Deviation 1.36
|
4.3 fold change
Standard Deviation 0.85
|
4.6 fold change
Standard Deviation 0.77
|
4.9 fold change
Standard Deviation 0.10
|
4.3 fold change
Standard Deviation 2.05
|
3.3 fold change
Standard Deviation 1.02
|
5.2 fold change
Standard Deviation 1.49
|
—
|
—
|
—
|
—
|
|
Phase 1: Fold Change From Baseline in Levels of TAK-981 Small Ubiquitin-like Modifier (SUMO) Adduct Formation in Blood Lymphocytes
Cycle 1 Day 8: Pre-dose
|
2.1 fold change
Standard Deviation 0.66
|
2.6 fold change
Standard Deviation 0.92
|
2.4 fold change
Standard Deviation 0.53
|
2.4 fold change
Standard Deviation 0.62
|
3.7 fold change
Standard Deviation 1.06
|
2.3 fold change
Standard Deviation 0.38
|
—
|
—
|
—
|
1.8 fold change
Standard Deviation 0.27
|
2.0 fold change
Standard Deviation 0.80
|
3.6 fold change
Standard Deviation 0.92
|
3.3 fold change
Standard Deviation 0.31
|
2.9 fold change
Standard Deviation 0.87
|
2.9 fold change
Standard Deviation 1.20
|
2.1 fold change
Standard Deviation 0.30
|
3.9 fold change
Standard Deviation 0.75
|
—
|
—
|
—
|
—
|
|
Phase 1: Fold Change From Baseline in Levels of TAK-981 Small Ubiquitin-like Modifier (SUMO) Adduct Formation in Blood Lymphocytes
Cycle 1 Day 8: 1 hour post-dose
|
7.4 fold change
Standard Deviation 2.95
|
7.5 fold change
Standard Deviation 2.18
|
9.6 fold change
Standard Deviation 1.74
|
8.4 fold change
Standard Deviation 2.68
|
9.2 fold change
Standard Deviation 1.79
|
8.2 fold change
Standard Deviation 1.94
|
—
|
—
|
—
|
3.2 fold change
Standard Deviation 0.72
|
3.8 fold change
Standard Deviation 1.73
|
8.0 fold change
Standard Deviation 3.03
|
7.9 fold change
Standard Deviation 2.00
|
8.4 fold change
Standard Deviation 2.20
|
9.6 fold change
Standard Deviation 3.94
|
6.9 fold change
Standard Deviation 0.89
|
8.7 fold change
Standard Deviation 2.91
|
—
|
—
|
—
|
—
|
|
Phase 1: Fold Change From Baseline in Levels of TAK-981 Small Ubiquitin-like Modifier (SUMO) Adduct Formation in Blood Lymphocytes
Cycle 1 Day 8: 4 hour post-dose
|
5.9 fold change
Standard Deviation 2.37
|
6.9 fold change
Standard Deviation 0.85
|
6.9 fold change
Standard Deviation 1.58
|
6.2 fold change
Standard Deviation 1.81
|
7.9 fold change
Standard Deviation 1.90
|
6.1 fold change
Standard Deviation 1.30
|
—
|
—
|
—
|
2.9 fold change
Standard Deviation 0.62
|
3.4 fold change
Standard Deviation 1.55
|
7.1 fold change
Standard Deviation 2.38
|
7.2 fold change
Standard Deviation 1.84
|
6.3 fold change
Standard Deviation 2.01
|
7.3 fold change
Standard Deviation 3.17
|
5.3 fold change
Standard Deviation 0.55
|
7.1 fold change
Standard Deviation 1.47
|
—
|
—
|
—
|
—
|
|
Phase 1: Fold Change From Baseline in Levels of TAK-981 Small Ubiquitin-like Modifier (SUMO) Adduct Formation in Blood Lymphocytes
Cycle 1 Day 8: 8 hour post-dose
|
5.2 fold change
Standard Deviation 2.05
|
5.8 fold change
Standard Deviation 1.19
|
5.7 fold change
Standard Deviation 1.05
|
5.8 fold change
Standard Deviation 2.04
|
5.9 fold change
Standard Deviation 0.83
|
5.2 fold change
Standard Deviation 1.06
|
—
|
—
|
—
|
2.9 fold change
Standard Deviation 0.65
|
3.2 fold change
Standard Deviation 1.53
|
6.7 fold change
Standard Deviation 1.98
|
6.0 fold change
Standard Deviation 1.42
|
6.1 fold change
Standard Deviation 2.45
|
6.3 fold change
Standard Deviation 2.63
|
4.3 fold change
Standard Deviation 0.59
|
6.6 fold change
Standard Deviation 1.68
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 8 (Cycle length = 21 days)Population: Pharmacodynamic analysis set consisted of participants who provided evaluable skin biopsies (screening sample and at least 1 on-treatment sample). Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
TAK-981-SUMO adduct formation in skin was tested by flow cytometry with an antibody recognizing the TAK-981-SUMO adduct formation during the inhibition of the SUMO-activating enzyme by TAK-981.
Outcome measures
| Measure |
Phase 1, Dose Escalation: TAK-981 75 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW
n=1 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW on Days 1, 8, 15
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1, 8 and 15 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort A, NSCLC: TAK-981 90 mg BIW
Participants with non-squamous non-small cell lung cancer (NSCLC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort B, Cervical Cancer: TAK-981 90 mg BIW
Participants with cervical cancer received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 3 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 3 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 6 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 6 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 10 mg BIW
n=1 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 10 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 15 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 15 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 25 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 25 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 40 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 40 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 75 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort C, MSS-CRC: TAK-981 90 mg BIW
Participants with microsatellite-stable colorectal cancer (MSS-CRC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort D, DLBCL After CAR T-cells Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) progressed or relapsed after chimeric antigen receptor (CAR) T-cell therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort E, DLBCL Without Prior Cellular Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory DLBCL that have not received prior cellular therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort F, Follicular Lymphoma: TAK-981 90 mg BIW
Participants with relapsed/refractory follicular lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Fold Change From Baseline in Levels of TAK-981 SUMO Adduct Formation in Skin
|
—
|
—
|
1343.23 fold change
Standard Deviation NA
Standard Deviation could not be estimated due to insufficient number of participants available for analysis.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
115.57 fold change
Standard Deviation NA
Standard Deviation could not be estimated due to insufficient number of participants available for analysis.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1: 1, 4 and 8 hours post-dose; Cycle 1 Day 8: Pre-dose, 1, 4 and 8 hours post-dose (Cycle length = 21 days)Population: Pharmacodynamic analysis set consisted of participants who provided evaluable blood samples (Cycle 1 Day 1 pre-dose sample and at least 1 post-dose sample). Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and here, "number analyzed" signifies participants evaluable at specified time-points.
SUMO pathway inhibition in peripheral blood lymphocytes was tested by flow cytometry with an antibody recognizing SUMO-2/3 chains.
Outcome measures
| Measure |
Phase 1, Dose Escalation: TAK-981 75 mg QW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg BIW
n=8 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW on Days 1, 8, 15
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1, 8 and 15 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg BIW
n=8 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg QW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort A, NSCLC: TAK-981 90 mg BIW
Participants with non-squamous non-small cell lung cancer (NSCLC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort B, Cervical Cancer: TAK-981 90 mg BIW
Participants with cervical cancer received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 3 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 3 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 6 mg BIW
n=3 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 6 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 10 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 10 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 15 mg BIW
n=3 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 15 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 25 mg BIW
n=3 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 25 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 40 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 40 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg BIW
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg QW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 75 mg BIW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort C, MSS-CRC: TAK-981 90 mg BIW
Participants with microsatellite-stable colorectal cancer (MSS-CRC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort D, DLBCL After CAR T-cells Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) progressed or relapsed after chimeric antigen receptor (CAR) T-cell therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort E, DLBCL Without Prior Cellular Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory DLBCL that have not received prior cellular therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort F, Follicular Lymphoma: TAK-981 90 mg BIW
Participants with relapsed/refractory follicular lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Fold Change From Baseline in SUMO Pathway Inhibition in Blood Lymphocytes
Cycle 1 Day 8: 1 hour post-dose
|
0.6 fold change
Standard Deviation 0.22
|
0.5 fold change
Standard Deviation 0.23
|
0.7 fold change
Standard Deviation 0.19
|
0.5 fold change
Standard Deviation 0.09
|
0.6 fold change
Standard Deviation 0.17
|
1.5 fold change
Standard Deviation 2.00
|
—
|
—
|
—
|
1.0 fold change
Standard Deviation 0.16
|
1.0 fold change
Standard Deviation 0.14
|
0.9 fold change
Standard Deviation 0.10
|
1.6 fold change
Standard Deviation 0.68
|
4.6 fold change
Standard Deviation 8.08
|
0.6 fold change
Standard Deviation 0.35
|
0.9 fold change
Standard Deviation 0.41
|
0.5 fold change
Standard Deviation 0.24
|
—
|
—
|
—
|
—
|
|
Phase 1: Fold Change From Baseline in SUMO Pathway Inhibition in Blood Lymphocytes
Cycle 1 Day 8: 4 hour post-dose
|
1.8 fold change
Standard Deviation 3.05
|
0.7 fold change
Standard Deviation 0.16
|
0.7 fold change
Standard Deviation 0.19
|
0.6 fold change
Standard Deviation 0.14
|
0.7 fold change
Standard Deviation 0.19
|
1.5 fold change
Standard Deviation 1.87
|
—
|
—
|
—
|
1.0 fold change
Standard Deviation 0.15
|
1.0 fold change
Standard Deviation 0.15
|
1.0 fold change
Standard Deviation 0.08
|
1.7 fold change
Standard Deviation 0.77
|
4.6 fold change
Standard Deviation 7.98
|
0.7 fold change
Standard Deviation 0.31
|
1.0 fold change
Standard Deviation 0.51
|
0.6 fold change
Standard Deviation 0.22
|
—
|
—
|
—
|
—
|
|
Phase 1: Fold Change From Baseline in SUMO Pathway Inhibition in Blood Lymphocytes
Cycle 1 Day 8: 8 hour post-dose
|
1.9 fold change
Standard Deviation 3.06
|
0.8 fold change
Standard Deviation 0.19
|
0.7 fold change
Standard Deviation 0.20
|
0.6 fold change
Standard Deviation 0.21
|
0.6 fold change
Standard Deviation 0.18
|
1.5 fold change
Standard Deviation 2.14
|
—
|
—
|
—
|
1.1 fold change
Standard Deviation 0.10
|
1.0 fold change
Standard Deviation 0.23
|
0.9 fold change
Standard Deviation 0.11
|
1.7 fold change
Standard Deviation 0.65
|
4.6 fold change
Standard Deviation 8.20
|
0.7 fold change
Standard Deviation 0.30
|
1.0 fold change
Standard Deviation 0.76
|
0.6 fold change
Standard Deviation 0.18
|
—
|
—
|
—
|
—
|
|
Phase 1: Fold Change From Baseline in SUMO Pathway Inhibition in Blood Lymphocytes
Cycle 1 Day 1: 8 hour post-dose
|
2.5 fold change
Standard Deviation 4.49
|
0.6 fold change
Standard Deviation 0.17
|
0.7 fold change
Standard Deviation 0.13
|
0.6 fold change
Standard Deviation 0.11
|
0.6 fold change
Standard Deviation 0.23
|
0.6 fold change
Standard Deviation 0.35
|
—
|
—
|
1.0 fold change
Standard Deviation 0.20
|
1.0 fold change
Standard Deviation 0.12
|
1.0 fold change
Standard Deviation 0.19
|
1.0 fold change
Standard Deviation 0.07
|
0.9 fold change
Standard Deviation 0.18
|
4.0 fold change
Standard Deviation 6.19
|
0.7 fold change
Standard Deviation 0.18
|
0.7 fold change
Standard Deviation 0.25
|
0.6 fold change
Standard Deviation 0.26
|
—
|
—
|
—
|
—
|
|
Phase 1: Fold Change From Baseline in SUMO Pathway Inhibition in Blood Lymphocytes
Cycle 1 Day 8: Pre-dose
|
1.0 fold change
Standard Deviation 0.16
|
0.8 fold change
Standard Deviation 0.43
|
1.1 fold change
Standard Deviation 0.27
|
1.0 fold change
Standard Deviation 0.18
|
1.1 fold change
Standard Deviation 0.21
|
2.8 fold change
Standard Deviation 3.74
|
—
|
—
|
—
|
1.0 fold change
Standard Deviation 0.17
|
1.0 fold change
Standard Deviation 0.15
|
1.1 fold change
Standard Deviation 0.16
|
1.7 fold change
Standard Deviation 0.82
|
5.5 fold change
Standard Deviation 9.42
|
2.1 fold change
Standard Deviation 3.57
|
1.5 fold change
Standard Deviation 0.66
|
1.0 fold change
Standard Deviation 0.24
|
—
|
—
|
—
|
—
|
|
Phase 1: Fold Change From Baseline in SUMO Pathway Inhibition in Blood Lymphocytes
Cycle 1 Day 1: 1 hour post-dose
|
0.6 fold change
Standard Deviation 0.11
|
0.6 fold change
Standard Deviation 0.11
|
0.6 fold change
Standard Deviation 0.12
|
0.6 fold change
Standard Deviation 0.09
|
0.5 fold change
Standard Deviation 0.07
|
0.6 fold change
Standard Deviation 0.22
|
—
|
—
|
1.0 fold change
Standard Deviation 0.04
|
1.0 fold change
Standard Deviation 0.05
|
0.9 fold change
Standard Deviation 0.11
|
0.9 fold change
Standard Deviation 0.04
|
0.9 fold change
Standard Deviation 0.06
|
4.7 fold change
Standard Deviation 7.88
|
0.8 fold change
Standard Deviation 0.13
|
0.7 fold change
Standard Deviation 0.13
|
0.6 fold change
Standard Deviation 0.14
|
—
|
—
|
—
|
—
|
|
Phase 1: Fold Change From Baseline in SUMO Pathway Inhibition in Blood Lymphocytes
Cycle 1 Day 1: 4 hour post-dose
|
2.5 fold change
Standard Deviation 4.74
|
0.6 fold change
Standard Deviation 0.13
|
0.6 fold change
Standard Deviation 0.18
|
0.6 fold change
Standard Deviation 0.11
|
0.5 fold change
Standard Deviation 0.14
|
0.6 fold change
Standard Deviation 0.36
|
—
|
—
|
0.9 fold change
Standard Deviation 0.15
|
1.0 fold change
Standard Deviation 0.07
|
1.0 fold change
Standard Deviation 0.07
|
0.9 fold change
Standard Deviation 0.05
|
1.0 fold change
Standard Deviation 0.09
|
4.1 fold change
Standard Deviation 6.38
|
2.3 fold change
Standard Deviation 4.03
|
0.9 fold change
Standard Deviation 0.41
|
0.5 fold change
Standard Deviation 0.20
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 8 (Cycle length = 21 days)Population: Pharmacodynamic analysis set consisted of participants who provided evaluable skin biopsies (screening sample and at least 1 on-treatment sample). Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
SUMO pathway inhibition in skin was tested by flow cytometry with an antibody recognizing SUMO-2/3 chains.
Outcome measures
| Measure |
Phase 1, Dose Escalation: TAK-981 75 mg QW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg BIW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW on Days 1, 8, 15
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1, 8 and 15 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg BIW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg QW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort A, NSCLC: TAK-981 90 mg BIW
Participants with non-squamous non-small cell lung cancer (NSCLC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort B, Cervical Cancer: TAK-981 90 mg BIW
Participants with cervical cancer received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 3 mg BIW
n=3 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 3 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 6 mg BIW
n=3 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 6 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 10 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 10 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 15 mg BIW
n=3 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 15 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 25 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 25 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 40 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 40 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg BIW
n=5 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg QW
n=5 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 75 mg BIW
n=6 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort C, MSS-CRC: TAK-981 90 mg BIW
Participants with microsatellite-stable colorectal cancer (MSS-CRC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort D, DLBCL After CAR T-cells Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) progressed or relapsed after chimeric antigen receptor (CAR) T-cell therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort E, DLBCL Without Prior Cellular Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory DLBCL that have not received prior cellular therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort F, Follicular Lymphoma: TAK-981 90 mg BIW
Participants with relapsed/refractory follicular lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Fold Change From Baseline in SUMO Pathway Inhibition in Skin
|
0.71 fold change
Standard Deviation 0.224
|
0.56 fold change
Standard Deviation 0.136
|
0.65 fold change
Standard Deviation 0.298
|
0.78 fold change
Standard Deviation 0.123
|
0.42 fold change
Standard Deviation 0.376
|
0.44 fold change
Standard Deviation 0.210
|
—
|
—
|
1.01 fold change
Standard Deviation 0.067
|
0.71 fold change
Standard Deviation 0.398
|
0.82 fold change
Standard Deviation 0.088
|
0.91 fold change
Standard Deviation 0.233
|
1.05 fold change
Standard Deviation 0.122
|
0.86 fold change
Standard Deviation 0.146
|
0.72 fold change
Standard Deviation 0.276
|
0.73 fold change
Standard Deviation 0.298
|
0.64 fold change
Standard Deviation 0.156
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the first dose of study drug through 30 days after the last dose of study drug (up to 12.2 months)Population: Safety analysis set consisted of participants who received at least 1 dose, even if incomplete, of study drug.
TEAEs were AEs that occurred after administration of the first dose of any study drug and through 30 days after the last dose of any 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. Any abnormal laboratory results were reported as TEAEs.
Outcome measures
| Measure |
Phase 1, Dose Escalation: TAK-981 75 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW on Days 1, 8, 15
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1, 8 and 15 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort A, NSCLC: TAK-981 90 mg BIW
Participants with non-squamous non-small cell lung cancer (NSCLC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort B, Cervical Cancer: TAK-981 90 mg BIW
Participants with cervical cancer received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 3 mg BIW
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 3 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 6 mg BIW
n=3 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 6 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 10 mg BIW
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 10 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 15 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 15 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 25 mg BIW
n=3 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 25 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 40 mg BIW
n=1 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 40 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 75 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort C, MSS-CRC: TAK-981 90 mg BIW
Participants with microsatellite-stable colorectal cancer (MSS-CRC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort D, DLBCL After CAR T-cells Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) progressed or relapsed after chimeric antigen receptor (CAR) T-cell therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort E, DLBCL Without Prior Cellular Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory DLBCL that have not received prior cellular therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort F, Follicular Lymphoma: TAK-981 90 mg BIW
Participants with relapsed/refractory follicular lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Number of Participants Reporting One or More TEAEs
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
6 Participants
|
3 Participants
|
7 Participants
|
4 Participants
|
3 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 12.2 months)Population: Safety analysis set consisted of participants who received at least 1 dose, even if incomplete, of study drug.
The severity grade was evaluated as per the CTCAE Version 5.0, except for CRS, which was assessed by ASTCT consensus grading. Where Grade 3 was severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL, Grade 4 was 4 Life-threatening consequences; urgent intervention indicated. and Grade 5 was death related to AE. TEAEs were AEs that occurred after administration of the first dose of any study drug and through 30 days after the last dose of any study drug.
Outcome measures
| Measure |
Phase 1, Dose Escalation: TAK-981 75 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW on Days 1, 8, 15
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1, 8 and 15 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort A, NSCLC: TAK-981 90 mg BIW
Participants with non-squamous non-small cell lung cancer (NSCLC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort B, Cervical Cancer: TAK-981 90 mg BIW
Participants with cervical cancer received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 3 mg BIW
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 3 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 6 mg BIW
n=3 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 6 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 10 mg BIW
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 10 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 15 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 15 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 25 mg BIW
n=3 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 25 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 40 mg BIW
n=1 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 40 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 75 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort C, MSS-CRC: TAK-981 90 mg BIW
Participants with microsatellite-stable colorectal cancer (MSS-CRC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort D, DLBCL After CAR T-cells Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) progressed or relapsed after chimeric antigen receptor (CAR) T-cell therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort E, DLBCL Without Prior Cellular Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory DLBCL that have not received prior cellular therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort F, Follicular Lymphoma: TAK-981 90 mg BIW
Participants with relapsed/refractory follicular lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Number of Participants With Grade 3 or Higher TEAEs
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4 Participants
|
1 Participants
|
6 Participants
|
3 Participants
|
3 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 12.2 months)Population: Safety analysis set consisted of participants who received at least 1 dose, even if incomplete, of study drug.
TEAEs were AEs that occurred after administration of the first dose of any study drug and through 30 days after the last dose of any 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.
Outcome measures
| Measure |
Phase 1, Dose Escalation: TAK-981 75 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW on Days 1, 8, 15
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1, 8 and 15 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort A, NSCLC: TAK-981 90 mg BIW
Participants with non-squamous non-small cell lung cancer (NSCLC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort B, Cervical Cancer: TAK-981 90 mg BIW
Participants with cervical cancer received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 3 mg BIW
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 3 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 6 mg BIW
n=3 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 6 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 10 mg BIW
n=7 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 10 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 15 mg BIW
n=4 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 15 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 25 mg BIW
n=3 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 25 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 40 mg BIW
n=1 Participants
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 40 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg QW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 75 mg BIW
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort C, MSS-CRC: TAK-981 90 mg BIW
Participants with microsatellite-stable colorectal cancer (MSS-CRC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort D, DLBCL After CAR T-cells Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) progressed or relapsed after chimeric antigen receptor (CAR) T-cell therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort E, DLBCL Without Prior Cellular Therapy: TAK-981 90 mg BIW
Participants with relapsed/refractory DLBCL that have not received prior cellular therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort F, Follicular Lymphoma: TAK-981 90 mg BIW
Participants with relapsed/refractory follicular lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Duration of TEAEs
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
8.5 days
Interval 1.0 to 336.0
|
4.0 days
Interval 1.0 to 45.0
|
5.0 days
Interval 1.0 to 72.0
|
5.0 days
Interval 1.0 to 26.0
|
3.0 days
Interval 1.0 to 19.0
|
1.0 days
Interval 1.0 to 56.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Phase 1, Dose Escalation: TAK-981 3 mg BIW
Serious events: 3 serious events
Other events: 4 other events
Deaths: 1 deaths
Phase 1, Dose Escalation: TAK-981 6 mg BIW
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 1, Dose Escalation: TAK-981 10 mg BIW
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Phase 1, Dose Escalation: TAK-981 15 mg BIW
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Phase 1, Dose Escalation: TAK-981 25 mg BIW
Serious events: 2 serious events
Other events: 4 other events
Deaths: 1 deaths
Phase 1, Dose Escalation: TAK-981 40 mg BIW
Serious events: 2 serious events
Other events: 4 other events
Deaths: 1 deaths
Phase 1, Dose Escalation: TAK-981 60 mg BIW
Serious events: 3 serious events
Other events: 6 other events
Deaths: 2 deaths
Phase 1, Dose Escalation: TAK-981 60 mg QW
Serious events: 1 serious events
Other events: 6 other events
Deaths: 1 deaths
Phase 1, Dose Escalation: TAK-981 75 mg BIW
Serious events: 3 serious events
Other events: 5 other events
Deaths: 1 deaths
Phase 1, Dose Escalation: TAK-981 75 mg QW
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase 1, Dose Escalation: TAK-981 90 mg BIW
Serious events: 5 serious events
Other events: 7 other events
Deaths: 2 deaths
Phase 1, Dose Escalation: TAK-981 90 mg QW
Serious events: 2 serious events
Other events: 7 other events
Deaths: 2 deaths
Phase 1, Dose Escalation: TAK-981 90 mg QW on Days 1, 8, 15
Serious events: 2 serious events
Other events: 7 other events
Deaths: 1 deaths
Phase 1, Dose Escalation: TAK-981 120 mg BIW
Serious events: 5 serious events
Other events: 8 other events
Deaths: 1 deaths
Phase 1, Dose Escalation: TAK-981 120 mg QW
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase 2, Dose Expansion, Cohort A, NSCLC: TAK-981 90 mg BIW
Serious events: 2 serious events
Other events: 6 other events
Deaths: 1 deaths
Phase 2, Dose Expansion, Cohort B, Cervical Cancer: TAK-981 90 mg BIW
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Phase 2, Dose Expansion, Cohort C, MSS-CRC: TAK-981 90 mg BIW
Serious events: 4 serious events
Other events: 7 other events
Deaths: 1 deaths
Phase 2, Dose Expansion, Cohort D, DLBCL After CAR T-cells Therapy: TAK-981 90 mg BIW
Serious events: 2 serious events
Other events: 4 other events
Deaths: 4 deaths
Phase 2, Dose Expansion, Cohort E, DLBCL Without Prior Cellular Therapy: TAK-981 90 mg BIW
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
Phase 2, Dose Expansion, Cohort F, Follicular Lymphoma: TAK-981 90 mg BIW
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 1, Dose Escalation: TAK-981 3 mg BIW
n=5 participants at risk
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 3 milligram (mg), infusion, intravenously, twice weekly (BIW) on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 6 mg BIW
n=3 participants at risk
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 6 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 10 mg BIW
n=4 participants at risk
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 10 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 15 mg BIW
n=3 participants at risk
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 15 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 25 mg BIW
n=4 participants at risk
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 25 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 40 mg BIW
n=4 participants at risk
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 40 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg BIW
n=7 participants at risk
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg QW
n=6 participants at risk
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, once weekly (QW) on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 75 mg BIW
n=6 participants at risk
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 75 mg QW
n=6 participants at risk
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg BIW
n=8 participants at risk
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW
n=7 participants at risk
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW on Days 1, 8, 15
n=7 participants at risk
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1, 8 and 15 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg BIW
n=8 participants at risk
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg QW
n=6 participants at risk
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort A, NSCLC: TAK-981 90 mg BIW
n=7 participants at risk
Participants with non-squamous non-small cell lung cancer (NSCLC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort B, Cervical Cancer: TAK-981 90 mg BIW
n=3 participants at risk
Participants with cervical cancer received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort C, MSS-CRC: TAK-981 90 mg BIW
n=7 participants at risk
Participants with microsatellite-stable colorectal cancer (MSS-CRC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort D, DLBCL After CAR T-cells Therapy: TAK-981 90 mg BIW
n=4 participants at risk
Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) progressed or relapsed after chimeric antigen receptor (CAR) T-cell therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort E, DLBCL Without Prior Cellular Therapy: TAK-981 90 mg BIW
n=3 participants at risk
Participants with relapsed/refractory DLBCL that have not received prior cellular therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort F, Follicular Lymphoma: TAK-981 90 mg BIW
n=1 participants at risk
Participants with relapsed/refractory follicular lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the tongue
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
1/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Infections and infestations
Appendicitis
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Infections and infestations
COVID-19
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Infections and infestations
Cystitis
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
28.6%
2/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Nervous system disorders
Dizziness postural
|
20.0%
1/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
General disorders
Fatigue
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Gastrointestinal disorders
Incarcerated umbilical hernia
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Gastrointestinal disorders
Intestinal mass
|
20.0%
1/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
20.0%
1/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
General disorders
Oedema peripheral
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
General disorders
Pain
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Investigations
Platelet count decreased
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Nervous system disorders
Presyncope
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
20.0%
1/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Gastrointestinal disorders
Rectal obstruction
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
1/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
Other adverse events
| Measure |
Phase 1, Dose Escalation: TAK-981 3 mg BIW
n=5 participants at risk
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 3 milligram (mg), infusion, intravenously, twice weekly (BIW) on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 6 mg BIW
n=3 participants at risk
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 6 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 10 mg BIW
n=4 participants at risk
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 10 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 15 mg BIW
n=3 participants at risk
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 15 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 25 mg BIW
n=4 participants at risk
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 25 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 40 mg BIW
n=4 participants at risk
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 40 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg BIW
n=7 participants at risk
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 60 mg QW
n=6 participants at risk
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 60 mg, infusion, intravenously, once weekly (QW) on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 75 mg BIW
n=6 participants at risk
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 75 mg QW
n=6 participants at risk
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 75 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg BIW
n=8 participants at risk
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW
n=7 participants at risk
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 90 mg QW on Days 1, 8, 15
n=7 participants at risk
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 90 mg, infusion, intravenously, QW on Days 1, 8 and 15 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg BIW
n=8 participants at risk
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 1, Dose Escalation: TAK-981 120 mg QW
n=6 participants at risk
Participants with relapsed/refractory advanced or metastatic solid tumors or lymphoma received TAK-981 120 mg, infusion, intravenously, QW on Days 1 and 8 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort A, NSCLC: TAK-981 90 mg BIW
n=7 participants at risk
Participants with non-squamous non-small cell lung cancer (NSCLC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort B, Cervical Cancer: TAK-981 90 mg BIW
n=3 participants at risk
Participants with cervical cancer received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort C, MSS-CRC: TAK-981 90 mg BIW
n=7 participants at risk
Participants with microsatellite-stable colorectal cancer (MSS-CRC) received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort D, DLBCL After CAR T-cells Therapy: TAK-981 90 mg BIW
n=4 participants at risk
Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) progressed or relapsed after chimeric antigen receptor (CAR) T-cell therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort E, DLBCL Without Prior Cellular Therapy: TAK-981 90 mg BIW
n=3 participants at risk
Participants with relapsed/refractory DLBCL that have not received prior cellular therapy received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
Phase 2, Dose Expansion, Cohort F, Follicular Lymphoma: TAK-981 90 mg BIW
n=1 participants at risk
Participants with relapsed/refractory follicular lymphoma received TAK-981 90 mg, infusion, intravenously, BIW on Days 1, 4, 8 and 11 in a 21-day treatment cycle until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the study or discontinuation of study drug occurred.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
General disorders
Chest pain
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
General disorders
Chills
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
66.7%
4/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
50.0%
4/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
42.9%
3/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
37.5%
3/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
2/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
85.7%
6/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Eye disorders
Diplopia
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer metastatic
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
General disorders
Complication associated with device
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
General disorders
Discomfort
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
50.0%
2/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
2/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
2/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
28.6%
2/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
1/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
2/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
2/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
28.6%
2/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
2/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
28.6%
2/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
2/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
2/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
2/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
62.5%
5/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
28.6%
2/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
50.0%
4/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
50.0%
3/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
28.6%
2/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
42.9%
3/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Renal and urinary disorders
Bladder pain
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Nervous system disorders
Dizziness
|
40.0%
2/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
28.6%
2/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
2/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
2/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Vascular disorders
Deep vein thrombosis
|
20.0%
1/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
37.5%
3/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Psychiatric disorders
Delirium
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Product Issues
Device dislocation
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Gastrointestinal disorders
Diarrhoea
|
40.0%
2/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
50.0%
2/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
42.9%
3/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
2/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
66.7%
4/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
50.0%
4/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
42.9%
3/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
42.9%
3/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
2/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
2/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
42.9%
3/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
57.1%
4/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
66.7%
2/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
42.9%
3/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
2/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Abdominal neoplasm
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
1/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
50.0%
4/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
28.6%
2/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
28.6%
2/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Investigations
Ammonia increased
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
2/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
2/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
28.6%
2/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
28.6%
2/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
2/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
57.1%
4/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
66.7%
2/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Eye disorders
Anisocoria
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
2/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
2/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
28.6%
2/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
2/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
28.6%
2/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
2/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
General disorders
Asthenia
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Nervous system disorders
Ataxia
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
General disorders
Axillary pain
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
28.6%
2/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
28.6%
2/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
28.6%
2/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
28.6%
2/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Eye disorders
Blepharitis
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Investigations
Blood antidiuretic hormone increased
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
28.6%
2/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
2/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Investigations
Blood creatine increased
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Investigations
Blood creatinine increased
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
28.6%
2/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Investigations
Body temperature increased
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Infections and infestations
Bronchitis
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Infections and infestations
COVID-19
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
28.6%
2/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
50.0%
2/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
100.0%
1/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
100.0%
1/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Cardiac disorders
Cardiac ventricular thrombosis
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
General disorders
Catheter site inflammation
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Eye disorders
Dry eye
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Gastrointestinal disorders
Dry mouth
|
20.0%
1/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
2/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
42.9%
3/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
28.6%
2/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
20.0%
1/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
42.9%
3/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
2/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
50.0%
4/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
28.6%
2/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
2/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
2/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
28.6%
2/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
28.6%
2/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
General disorders
Fatigue
|
20.0%
1/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
50.0%
2/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
50.0%
2/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
50.0%
2/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
57.1%
4/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
83.3%
5/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
66.7%
4/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
66.7%
4/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
62.5%
5/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
28.6%
2/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
71.4%
5/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
37.5%
3/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
2/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
42.9%
3/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
57.1%
4/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Eye disorders
Eye pruritus
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
General disorders
Face oedema
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Gastrointestinal disorders
Faeces pale
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Vascular disorders
Flushing
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
20.0%
1/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
General disorders
Gait disturbance
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
28.6%
2/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Skin and subcutaneous tissue disorders
Hair texture abnormal
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Psychiatric disorders
Hallucination, visual
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Nervous system disorders
Headache
|
40.0%
2/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
66.7%
2/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
50.0%
2/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
2/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
83.3%
5/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
50.0%
4/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
57.1%
4/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
57.1%
4/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
50.0%
3/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
28.6%
2/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
57.1%
4/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Infections and infestations
Herpes simplex reactivation
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
28.6%
2/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Vascular disorders
Hot flush
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
28.6%
2/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
28.6%
2/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
2/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
100.0%
1/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Vascular disorders
Hypertension
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
28.6%
2/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
50.0%
3/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
37.5%
3/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
28.6%
2/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
28.6%
2/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
37.5%
3/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
100.0%
1/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
2/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
28.6%
2/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
2/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
28.6%
2/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
2/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
2/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Vascular disorders
Hypotension
|
20.0%
1/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
2/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
General disorders
Influenza like illness
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
2/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
General disorders
Infusion site bruising
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
General disorders
Infusion site pain
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
General disorders
Injection site bruising
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
General disorders
Injection site pain
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
50.0%
3/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
2/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
2/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
28.6%
2/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Investigations
Interferon alpha level increased
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
100.0%
1/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Investigations
Interferon gamma level increased
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
100.0%
1/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Investigations
Interleukin level increased
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
100.0%
1/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Nervous system disorders
Lethargy
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Renal and urinary disorders
Leukocyturia
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Gastrointestinal disorders
Lip blister
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Gastrointestinal disorders
Lip scab
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
General disorders
Malaise
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant peritoneal neoplasm
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Psychiatric disorders
Middle insomnia
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
28.6%
2/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
50.0%
2/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
66.7%
2/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
General disorders
Mucosal inflammation
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
20.0%
1/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
28.6%
2/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
28.6%
2/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
2/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Gastrointestinal disorders
Nausea
|
40.0%
2/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
28.6%
2/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
2/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
2/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
100.0%
6/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
75.0%
6/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
71.4%
5/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
71.4%
5/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
62.5%
5/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
50.0%
3/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
66.7%
2/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
100.0%
1/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
28.6%
2/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
28.6%
2/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
2/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
General disorders
Oedema peripheral
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
2/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
2/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
42.9%
3/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
2/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
28.6%
2/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Nervous system disorders
Ophthalmic migraine
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
2/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Infections and infestations
Oral herpes
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
2/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Infections and infestations
Otitis media
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
General disorders
Pain
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Cardiac disorders
Palpitations
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Gastrointestinal disorders
Pancreatic failure
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Investigations
Platelet count decreased
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
2/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
100.0%
1/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Nervous system disorders
Paraesthesia
|
20.0%
1/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Infections and infestations
Paronychia
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Infections and infestations
Parotitis
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
General disorders
Performance status decreased
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
General disorders
Peripheral swelling
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Vascular disorders
Phlebitis
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
28.6%
2/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
28.6%
2/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Nervous system disorders
Tremor
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Investigations
Pleural fluid analysis abnormal
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Nervous system disorders
Presyncope
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Investigations
Prothrombin level increased
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
100.0%
1/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
2/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
General disorders
Pyrexia
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
28.6%
2/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
50.0%
3/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
50.0%
3/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
50.0%
4/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
28.6%
2/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
28.6%
2/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
75.0%
6/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
50.0%
3/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
28.6%
2/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
71.4%
5/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
100.0%
1/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Skin and subcutaneous tissue disorders
Scab
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
28.6%
2/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
2/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Infections and infestations
Sinusitis
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Nervous system disorders
Somnolence
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Musculoskeletal and connective tissue disorders
Spondylitis
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Injury, poisoning and procedural complications
Stoma prolapse
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
50.0%
2/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
37.5%
3/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
General disorders
Thirst
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Renal and urinary disorders
Urinary incontinence
|
20.0%
1/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
50.0%
2/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Investigations
Urinary occult blood
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
100.0%
1/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Eye disorders
Vision blurred
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
1/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
50.0%
3/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
50.0%
4/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
42.9%
3/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
57.1%
4/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
50.0%
4/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
50.0%
3/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
25.0%
1/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Reproductive system and breast disorders
Vulvovaginal inflammation
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
20.0%
1/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Investigations
Weight decreased
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
14.3%
1/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
2/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
28.6%
2/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
100.0%
1/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Investigations
White blood cell count decreased
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
33.3%
1/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
100.0%
1/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
|
Investigations
White blood cell count increased
|
0.00%
0/5 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
16.7%
1/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
12.5%
1/8 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/6 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/7 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/4 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/3 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
0.00%
0/1 • Serious and Other (Non-serious) AEs: From the first dose of study drug through 30 days after the last dose of study drug up to 35.3 months (for Phase 1) and up to 12.2 months (for Phase 2); All-cause mortality: From date of first dose of study drug up to death due to any cause (up to 34.3 months for Phase 1 and up to 11.2 months for Phase 2)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place