Trial Outcomes & Findings for A Study of HMPL-306 in Advanced Solid Tumors With IDH Mutations (NCT NCT04762602)
NCT ID: NCT04762602
Last Updated: 2026-03-27
Results Overview
RP2D determination took the following criteria under consideration: determination of maximum tolerated dose (MTD) achieved during the dose escalation part and assessment of safety, pharmacokinetics (PK) and pharmacodynamics (PD). The modified toxicity probability interval-2 design was used to perform dose escalation and planned to determine MTD/RP2D.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
42 participants
Primary outcome timeframe
From the first dose of study drug (Day 1) up to Day 28 of Cycle 1
Results posted on
2026-03-27
Participant Flow
This Phase 1, open-label study was conducted in patients with locally advanced or metastatic solid tumors with isocitrate dehydrogenase (IDH) mutations and consisted of dose escalation part (Part 1) and dose expansion part (Part 2).
The study was terminated based on strategic evaluation of the clinical development of HMPL-306 with no safety concerns. At the time of study termination, patients had not entered the dose expansion part (Part 2) of the study (it was never initiated). 42 patients were enrolled in the dose escalation part.
Participant milestones
| Measure |
Part 1: Cohort-8: HMPL-306 400 mg
Patients with locally advanced or metastatic solid tumors received HMPL-306 400 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-1: HMPL-306 50 mg
Patients with locally advanced or metastatic solid tumors received HMPL-306 50 milligrams (mg) tablet orally once daily (QD) in a 28-day continuous dosing treatment cycle until disease progression (Pd), initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-2: HMPL-306 100 mg
Patients with locally advanced or metastatic solid tumors received HMPL-306 100 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-3: HMPL-306 150 mg
Patients with locally advanced or metastatic solid tumors received HMPL-306 150 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-4: HMPL-306 200 mg
Patients with locally advanced or metastatic solid tumors received HMPL-306 200 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-5: HMPL-306 250 mg
Patients with locally advanced or metastatic solid tumors received HMPL-306 250 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-6: HMPL-306 300 mg
Patients with locally advanced or metastatic solid tumors received HMPL-306 300 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-7: HMPL-306 350 mg
Patients with locally advanced or metastatic solid tumors received HMPL-306 350 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
3
|
3
|
5
|
12
|
6
|
4
|
4
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
3
|
5
|
12
|
6
|
4
|
4
|
Reasons for withdrawal
| Measure |
Part 1: Cohort-8: HMPL-306 400 mg
Patients with locally advanced or metastatic solid tumors received HMPL-306 400 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-1: HMPL-306 50 mg
Patients with locally advanced or metastatic solid tumors received HMPL-306 50 milligrams (mg) tablet orally once daily (QD) in a 28-day continuous dosing treatment cycle until disease progression (Pd), initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-2: HMPL-306 100 mg
Patients with locally advanced or metastatic solid tumors received HMPL-306 100 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-3: HMPL-306 150 mg
Patients with locally advanced or metastatic solid tumors received HMPL-306 150 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-4: HMPL-306 200 mg
Patients with locally advanced or metastatic solid tumors received HMPL-306 200 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-5: HMPL-306 250 mg
Patients with locally advanced or metastatic solid tumors received HMPL-306 250 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-6: HMPL-306 300 mg
Patients with locally advanced or metastatic solid tumors received HMPL-306 300 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-7: HMPL-306 350 mg
Patients with locally advanced or metastatic solid tumors received HMPL-306 350 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Other
|
5
|
3
|
3
|
3
|
11
|
3
|
4
|
3
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
1
|
|
Overall Study
Death
|
0
|
0
|
0
|
1
|
1
|
2
|
0
|
0
|
Baseline Characteristics
A Study of HMPL-306 in Advanced Solid Tumors With IDH Mutations
Baseline characteristics by cohort
| Measure |
Part 1: Cohort-8: HMPL-306 400 mg
n=5 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 400 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Total
n=42 Participants
Total of all reporting groups
|
Part 1: Cohort-1: HMPL-306 50 mg
n=3 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 50 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-2: HMPL-306 100 mg
n=3 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 100 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-3: HMPL-306 150 mg
n=5 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 150 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-4: HMPL-306 200 mg
n=12 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 200 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-5: HMPL-306 250 mg
n=6 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 250 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-6: HMPL-306 300 mg
n=4 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 300 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-7: HMPL-306 350 mg
n=4 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 350 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
53.0 years
STANDARD_DEVIATION 16.32 • n=12 Participants
|
53.5 years
STANDARD_DEVIATION 13.67 • n=6 Participants
|
48.3 years
STANDARD_DEVIATION 19.04 • n=56 Participants
|
54.0 years
STANDARD_DEVIATION 9.64 • n=62 Participants
|
55.4 years
STANDARD_DEVIATION 10.69 • n=123 Participants
|
53.0 years
STANDARD_DEVIATION 19.29 • n=53 Participants
|
52.3 years
STANDARD_DEVIATION 9.71 • n=654 Participants
|
54.8 years
STANDARD_DEVIATION 11.53 • n=120 Participants
|
57.3 years
STANDARD_DEVIATION 5.56 • n=18 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=12 Participants
|
17 Participants
n=6 Participants
|
2 Participants
n=56 Participants
|
2 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
5 Participants
n=53 Participants
|
3 Participants
n=654 Participants
|
2 Participants
n=120 Participants
|
0 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=12 Participants
|
25 Participants
n=6 Participants
|
1 Participants
n=56 Participants
|
1 Participants
n=62 Participants
|
5 Participants
n=123 Participants
|
7 Participants
n=53 Participants
|
3 Participants
n=654 Participants
|
2 Participants
n=120 Participants
|
4 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=12 Participants
|
4 Participants
n=6 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
3 Participants
n=53 Participants
|
1 Participants
n=654 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=12 Participants
|
37 Participants
n=6 Participants
|
2 Participants
n=56 Participants
|
3 Participants
n=62 Participants
|
5 Participants
n=123 Participants
|
9 Participants
n=53 Participants
|
5 Participants
n=654 Participants
|
4 Participants
n=120 Participants
|
4 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=12 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=654 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=18 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=12 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=56 Participants
|
1 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=654 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=18 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=12 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
1 Participants
n=123 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=654 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=18 Participants
|
|
Race/Ethnicity, Customized
White
|
5 Participants
n=12 Participants
|
38 Participants
n=6 Participants
|
2 Participants
n=56 Participants
|
2 Participants
n=62 Participants
|
4 Participants
n=123 Participants
|
11 Participants
n=53 Participants
|
6 Participants
n=654 Participants
|
4 Participants
n=120 Participants
|
4 Participants
n=18 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 Participants
n=12 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=654 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=18 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=12 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
1 Participants
n=53 Participants
|
0 Participants
n=654 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=18 Participants
|
PRIMARY outcome
Timeframe: From the first dose of study drug (Day 1) up to Day 28 of Cycle 1Population: The safety analysis set included all enrolled patients who received at least 1 dose of study drug.
RP2D determination took the following criteria under consideration: determination of maximum tolerated dose (MTD) achieved during the dose escalation part and assessment of safety, pharmacokinetics (PK) and pharmacodynamics (PD). The modified toxicity probability interval-2 design was used to perform dose escalation and planned to determine MTD/RP2D.
Outcome measures
| Measure |
Part 1: Cohort-7: HMPL-306 350 mg
Patients with locally advanced or metastatic solid tumors received HMPL-306 350 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohorts-1 to 8: HMPL-306
n=42 Participants
All patients enrolled in the dose escalation part (Part 1: Cohorts-1 to 8) were included in this arm.
|
Part 1: Cohort-2: HMPL-306 100 mg
Patients with locally advanced or metastatic solid tumors received HMPL-306 100 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-3: HMPL-306 150 mg
Patients with locally advanced or metastatic solid tumors received HMPL-306 150 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-4: HMPL-306 200 mg
Patients with locally advanced or metastatic solid tumors received HMPL-306 200 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-5: HMPL-306 250 mg
Patients with locally advanced or metastatic solid tumors received HMPL-306 250 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-6: HMPL-306 300 mg
Patients with locally advanced or metastatic solid tumors received HMPL-306 300 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-8: HMPL-306 400 mg
Patients with locally advanced or metastatic solid tumors received HMPL-306 400 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Recommended Phase 2 Dose (RP2D) of HMPL-306
|
—
|
NA milligrams
The MTD was not reached up to the explored highest dose (400 mg) and the RP2D was not determined in the study.
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From the first dose of study drug (Day 1) up to Day 28 of Cycle 1Population: Analysis was performed on the DLT-evaluable analysis set for all patients enrolled in Part 1 of the study. A patient was DLT-evaluable if met the following criteria: had received at least 75% of the assigned dose of study drug during the DLT assessment window or had not completed DLT assessment period due to a DLT.
DLT:occurrence of any of following treatment-emergent adverse events (TEAEs) during DLT assessment window unless clearly unrelated to study drug/judged by investigator as not clinically significant: 1. Non-hematologic:TEAEs Grade \>=4, Grade 3 except those which recovered to Grade \<=1 within 3 days after supportive therapy administered for nausea,vomiting,diarrhea,constipation,fatigue,electrolyte imbalance;Grade 3 hypothyroidism, adrenal gland or pituitary insufficiency, and inflammatory reactions at tumor site \& Grade 3 hypertension downgraded to Grade \<=1 within 1 week with appropriate supportive therapy. 2. Hematologic:Grade \>=3 febrile neutropenia;Grade 4 neutropenia or thrombocytopenia;Grade 3 thrombocytopenia with clinically significant bleeding in addition to that requiring transfusion;Grade 4 anemia requiring a dose delay of \>=14 days. 3. Any life-threatening complication/abnormality not covered in National Cancer Institute Common Terminology Criteria for AEs version(v) 5.0.
Outcome measures
| Measure |
Part 1: Cohort-7: HMPL-306 350 mg
n=4 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 350 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohorts-1 to 8: HMPL-306
n=3 Participants
All patients enrolled in the dose escalation part (Part 1: Cohorts-1 to 8) were included in this arm.
|
Part 1: Cohort-2: HMPL-306 100 mg
n=3 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 100 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-3: HMPL-306 150 mg
n=3 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 150 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-4: HMPL-306 200 mg
n=12 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 200 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-5: HMPL-306 250 mg
n=6 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 250 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-6: HMPL-306 300 mg
n=4 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 300 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-8: HMPL-306 400 mg
n=4 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 400 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Number of Patients With Dose-limiting Toxicities (DLTs)
|
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 (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1Population: The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
AE:unfavorable,unintended sign,symptom or disease temporally associated with use of study drug or other protocol-imposed drug, whether or not considered drug related. SAE:AE that resulted in death, was life threatening, inpatient hospitalization/prolongation of existing hospitalization, persistent/significant incapacity or substantial disruption of ability to conduct normal life functions, congenital anomaly/birth defect, important medical event that jeopardized patient and required medical/surgical intervention to prevent above outcome or signs, symptoms or clinical sequelae of suspected overdose of either study drug or a concomitant medication. TEAE:AE with onset on/after start of study drug until 30 days after last dose or prior to start of subsequent anti-tumor therapy, or AE with onset before start of study drug but worsened in severity after study drug administration or beyond 30 days after last dose or after start of subsequent anti-tumor therapy and treatment-related SAEs.
Outcome measures
| Measure |
Part 1: Cohort-7: HMPL-306 350 mg
n=4 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 350 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohorts-1 to 8: HMPL-306
n=3 Participants
All patients enrolled in the dose escalation part (Part 1: Cohorts-1 to 8) were included in this arm.
|
Part 1: Cohort-2: HMPL-306 100 mg
n=3 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 100 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-3: HMPL-306 150 mg
n=5 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 150 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-4: HMPL-306 200 mg
n=12 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 200 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-5: HMPL-306 250 mg
n=6 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 250 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-6: HMPL-306 300 mg
n=4 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 300 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-8: HMPL-306 400 mg
n=5 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 400 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Parts 1 and 2: Number of Patients With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events (TESAEs)
TEAEs
|
4 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
11 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
|
Parts 1 and 2: Number of Patients With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events (TESAEs)
TESAEs
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Tumor assessments performed every 8 weeks (+/-1 week) from Cycle 1 Day 1 for the first 24 weeks and every 12 weeks (+/-2 weeks) thereafter until end of treatment or end of efficacy follow-up period, approximately 47 months for Part 1Population: The response evaluable analysis set included all patients who were in the safety analysis set and had a measurable lesion at the baseline tumor assessment, and either (i) had at least 1 post-dose tumor assessment, or (ii) did not have post-dose tumor assessment but had clinical progression as noted by the investigator, or died before their first post-dose tumor scan. Due to early study termination, Part 2 was never initiated.
ORR by response evaluation criteria in solid tumors (RECIST) v1.1 was defined as the percentage of patients with confirmed best overall response (BOR) of complete response (CR) or partial response (PR) as determined by the investigator. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. ORR by response assessment in neuro-oncology criteria (RANO) was defined as the percentage of patients with a BOR of CR or PR or minor response (MR) as determined by the investigator using RANO criteria mentioned in protocol for glioma patients.
Outcome measures
| Measure |
Part 1: Cohort-7: HMPL-306 350 mg
n=2 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 350 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohorts-1 to 8: HMPL-306
n=3 Participants
All patients enrolled in the dose escalation part (Part 1: Cohorts-1 to 8) were included in this arm.
|
Part 1: Cohort-2: HMPL-306 100 mg
n=3 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 100 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-3: HMPL-306 150 mg
n=4 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 150 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-4: HMPL-306 200 mg
n=12 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 200 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-5: HMPL-306 250 mg
n=5 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 250 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-6: HMPL-306 300 mg
n=4 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 300 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-8: HMPL-306 400 mg
n=5 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 400 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Parts 1 and 2: Objective Response Rate (ORR)
|
0 percentage of patients
Interval 0.0 to 84.2
|
0 percentage of patients
Interval 0.0 to 70.8
|
33.3 percentage of patients
Interval 0.8 to 90.6
|
0 percentage of patients
Interval 0.0 to 60.2
|
8.3 percentage of patients
Interval 0.2 to 38.5
|
20.0 percentage of patients
Interval 0.5 to 71.6
|
0 percentage of patients
Interval 0.0 to 60.2
|
0 percentage of patients
Interval 0.0 to 52.2
|
SECONDARY outcome
Timeframe: Tumor assessments performed every 8 weeks (+/-1 week) from Cycle 1 Day 1 for the first 24 weeks and every 12 weeks (+/-2 weeks) thereafter until end of treatment or end of efficacy follow-up period, approximately 47 months for Part 1Population: The response evaluable analysis set included all patients who were in the safety analysis set and had a measurable lesion at the baseline tumor assessment, and either (i) had at least 1 post-dose tumor assessment, or (ii) did not have post-dose tumor assessment but had clinical progression as noted by the investigator, or died before their first post-dose tumor scan. Due to early study termination, Part 2 was never initiated.
DCR by RECIST v1.1 was defined as percentage of patients with BOR of CR, PR, or stable disease (SD) lasting at least 7 weeks as determined by investigator.CR: disappearance of all target lesions.PR: at least a 30% decrease in sum of diameters of target lesions, taking as reference baseline sum of diameters.SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Pd, taking as reference the smallest sum on study. Pd: at least 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study (nadir), including baseline. In addition to relative increase of 20%, sum must also demonstrate an absolute increase of at least 5 millimeters (mm). The appearance of 1 or more new lesions was also considered progression. DCR by RANO was defined as percentage of patients with BOR of CR, PR, MR, or SD lasting at least 7 weeks as determined by investigator using RANO criteria mentioned in protocol for glioma patients.
Outcome measures
| Measure |
Part 1: Cohort-7: HMPL-306 350 mg
n=2 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 350 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohorts-1 to 8: HMPL-306
n=3 Participants
All patients enrolled in the dose escalation part (Part 1: Cohorts-1 to 8) were included in this arm.
|
Part 1: Cohort-2: HMPL-306 100 mg
n=3 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 100 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-3: HMPL-306 150 mg
n=4 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 150 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-4: HMPL-306 200 mg
n=12 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 200 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-5: HMPL-306 250 mg
n=5 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 250 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-6: HMPL-306 300 mg
n=4 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 300 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-8: HMPL-306 400 mg
n=5 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 400 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Parts 1 and 2: Disease Control Rate (DCR)
|
50.0 percentage of patients
Interval 1.3 to 98.7
|
0 percentage of patients
Interval 0.0 to 70.8
|
66.7 percentage of patients
Interval 9.4 to 99.2
|
50.0 percentage of patients
Interval 6.8 to 93.2
|
66.7 percentage of patients
Interval 34.9 to 90.1
|
60.0 percentage of patients
Interval 14.7 to 94.7
|
75.0 percentage of patients
Interval 19.4 to 99.4
|
40.0 percentage of patients
Interval 5.3 to 85.3
|
SECONDARY outcome
Timeframe: Tumor assessments performed every 8 weeks (+/-1 week) from Cycle 1 Day 1 for the first 24 weeks and every 12 weeks (+/-2 weeks) thereafter until end of treatment or end of efficacy follow-up period, approximately 47 months for Part 1Population: The response evaluable analysis set included all patients who were in the safety analysis set and had a measurable lesion at the baseline tumor assessment, and either (i) had at least 1 post-dose tumor assessment, or (ii) did not have post-dose tumor assessment but had clinical progression as noted by the investigator, or died before their first post-dose tumor scan. Only those patients with objective responses of confirmed CR or confirmed PR were included in this analysis.
DoR by RECIST v1.1 was defined as the time from the first occurrence of confirmed PR or confirmed CR until Pd or death, whichever came first. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Pd: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. DoR by RANO was defined as the time from the first occurrence of CR or PR or MR using RANO criteria mentioned in protocol for glioma patients, until disease progression or death, whichever comes first. Due to early study termination, Part 2 was never initiated.
Outcome measures
| Measure |
Part 1: Cohort-7: HMPL-306 350 mg
Patients with locally advanced or metastatic solid tumors received HMPL-306 350 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohorts-1 to 8: HMPL-306
All patients enrolled in the dose escalation part (Part 1: Cohorts-1 to 8) were included in this arm.
|
Part 1: Cohort-2: HMPL-306 100 mg
n=1 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 100 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-3: HMPL-306 150 mg
Patients with locally advanced or metastatic solid tumors received HMPL-306 150 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-4: HMPL-306 200 mg
n=1 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 200 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-5: HMPL-306 250 mg
n=1 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 250 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-6: HMPL-306 300 mg
Patients with locally advanced or metastatic solid tumors received HMPL-306 300 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-8: HMPL-306 400 mg
Patients with locally advanced or metastatic solid tumors received HMPL-306 400 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Parts 1 and 2: Duration of Response (DoR)
|
—
|
—
|
NA months
NA indicates that median, upper and lower limits of 95% confidence interval (CI) were not estimable due to insufficient number of patients with 1/1 patient censored prior to any event.
|
—
|
16.8 months
NA indicates that upper and lower limits of 95% CI were not estimable for only 1 patient.
|
NA months
NA indicates that median, upper and lower limits of 95% confidence interval (CI) were not estimable due to insufficient number of patients with 1/1 patient censored prior to any event.
|
—
|
—
|
SECONDARY outcome
Timeframe: Tumor assessments performed every 8 weeks (+/-1 week) from Cycle 1 Day 1 for the first 24 weeks and every 12 weeks (+/-2 weeks) thereafter until end of treatment or end of efficacy follow-up period, approximately 47 months for Part 1Population: The response evaluable analysis set included all patients who were in the safety analysis set and had a measurable lesion at the baseline tumor assessment, and either (i) had at least 1 post-dose tumor assessment, or (ii) did not have post-dose tumor assessment but had clinical progression as noted by the investigator, or died before their first post-dose tumor scan. Only those patients whose BOR was either confirmed CR or confirmed PR were included in this analysis.
TTR by RECIST v1.1 was defined as the time from start of study treatment until the date of first documented objective response, either confirmed CR or confirmed PR (whichever status was recorded first). CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. TTR by RANO was defined as the time from start of study treatment until the date of first documented objective response, either CR or PR or MR (whichever status was recorded first) using RANO criteria mentioned in protocol for glioma patients. Due to early study termination, Part 2 was never initiated.
Outcome measures
| Measure |
Part 1: Cohort-7: HMPL-306 350 mg
Patients with locally advanced or metastatic solid tumors received HMPL-306 350 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohorts-1 to 8: HMPL-306
All patients enrolled in the dose escalation part (Part 1: Cohorts-1 to 8) were included in this arm.
|
Part 1: Cohort-2: HMPL-306 100 mg
n=1 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 100 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-3: HMPL-306 150 mg
Patients with locally advanced or metastatic solid tumors received HMPL-306 150 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-4: HMPL-306 200 mg
n=1 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 200 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-5: HMPL-306 250 mg
n=1 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 250 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-6: HMPL-306 300 mg
Patients with locally advanced or metastatic solid tumors received HMPL-306 300 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-8: HMPL-306 400 mg
Patients with locally advanced or metastatic solid tumors received HMPL-306 400 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Parts 1 and 2: Time to Response (TTR)
|
—
|
—
|
2.1 months
NA indicates that upper and lower limits of 95% CI were not estimable for only 1 patient.
|
—
|
3.7 months
NA indicates that upper and lower limits of 95% CI were not estimable for only 1 patient.
|
22.1 months
NA indicates that upper and lower limits of 95% CI were not estimable for only 1 patient.
|
—
|
—
|
SECONDARY outcome
Timeframe: Tumor assessments performed every 8 weeks (+/-1 week) from Cycle 1 Day 1 for the first 24 weeks and every 12 weeks (+/-2 weeks) thereafter until end of treatment or end of efficacy follow-up period, approximately 47 months for Part 1Population: The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
PFS was defined as the time from the date of first administration of study drug until the first radiographic documentation of objective progression as assessed by investigator using RECIST v1.1 or RANO criteria for glioma patients, or death from any cause. As per RECIST v1.1: Pd: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions was also considered progression. Criteria for RANO as mentioned in protocol.
Outcome measures
| Measure |
Part 1: Cohort-7: HMPL-306 350 mg
n=4 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 350 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohorts-1 to 8: HMPL-306
n=3 Participants
All patients enrolled in the dose escalation part (Part 1: Cohorts-1 to 8) were included in this arm.
|
Part 1: Cohort-2: HMPL-306 100 mg
n=3 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 100 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-3: HMPL-306 150 mg
n=5 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 150 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-4: HMPL-306 200 mg
n=12 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 200 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-5: HMPL-306 250 mg
n=6 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 250 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-6: HMPL-306 300 mg
n=4 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 300 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-8: HMPL-306 400 mg
n=5 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 400 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Parts 1 and 2: Progression-free Survival (PFS)
|
NA months
NA indicates that median, upper and lower limits of 95% confidence interval (CI) were not estimable due to insufficient number of patients with 4/4 patients censored prior to any event.
|
1.9 months
Interval 1.8 to
NA indicates that upper limit of 95% CI was not estimable due to insufficient number of patients with events at study termination.
|
5.5 months
Interval 1.8 to
NA indicates that upper limit of 95% CI was not estimable due to insufficient number of patients with events at study termination.
|
2.7 months
Interval 0.8 to
NA indicates that upper limit of 95% CI was not estimable due to insufficient number of patients with events at study termination.
|
5.6 months
Interval 1.7 to 12.9
|
3.7 months
Interval 1.7 to
NA indicates that upper limit of 95% CI was not estimable due to insufficient number of patients with events at study termination.
|
8.3 months
Interval 1.6 to
NA indicates that upper limit of 95% CI was not estimable due to insufficient number of patients with events at study termination.
|
1.9 months
Interval 0.6 to
NA indicates that upper limit of 95% CI was not estimable due to insufficient number of patients with events at study termination.
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8 and 24 hours post-dose on Day 1 of Cycles 1 and 2 for Part 1Population: The PK parameters analysis set included all patients who received at least 1 dose of the study drug and had a sufficient PK profile to derive at least 1 PK parameter. Only those patients with data collected at specified timepoints are reported. Due to early study termination, Part 2 was never initiated.
Blood samples were collected at the specified timepoints to determine Cmax of HMPL-306.
Outcome measures
| Measure |
Part 1: Cohort-7: HMPL-306 350 mg
n=3 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 350 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohorts-1 to 8: HMPL-306
n=3 Participants
All patients enrolled in the dose escalation part (Part 1: Cohorts-1 to 8) were included in this arm.
|
Part 1: Cohort-2: HMPL-306 100 mg
n=3 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 100 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-3: HMPL-306 150 mg
n=5 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 150 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-4: HMPL-306 200 mg
n=10 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 200 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-5: HMPL-306 250 mg
n=6 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 250 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-6: HMPL-306 300 mg
n=4 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 300 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-8: HMPL-306 400 mg
n=5 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 400 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Parts 1 and 2: Maximum Observed Plasma Concentration (Cmax) of HMPL-306
Cycle 1 Day 1
|
670 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 51.9
|
181 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 17.5
|
487 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 35.1
|
365 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 26.6
|
550 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 43.2
|
596 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 35.6
|
645 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 38.9
|
885 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 45.7
|
|
Parts 1 and 2: Maximum Observed Plasma Concentration (Cmax) of HMPL-306
Cycle 2 Day 1
|
1758 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 61.2
|
414 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 34.3
|
891 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 30.1
|
1025 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 6.0
|
1633 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 26.0
|
1721 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 15.5
|
1943 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 71.7
|
3665 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 36.1
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8 and 24 hours post-dose on Day 1 of Cycles 1 and 2 for Part 1Population: The PK parameters analysis set included all patients who received at least 1 dose of the study drug and had a sufficient PK profile to derive at least 1 PK parameter. Only those patients with data collected at specified timepoints are reported. Due to early study termination, Part 2 was never initiated.
Blood samples were collected at the specified timepoints to determine Tmax of HMPL-306.
Outcome measures
| Measure |
Part 1: Cohort-7: HMPL-306 350 mg
n=3 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 350 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohorts-1 to 8: HMPL-306
n=3 Participants
All patients enrolled in the dose escalation part (Part 1: Cohorts-1 to 8) were included in this arm.
|
Part 1: Cohort-2: HMPL-306 100 mg
n=3 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 100 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-3: HMPL-306 150 mg
n=5 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 150 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-4: HMPL-306 200 mg
n=10 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 200 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-5: HMPL-306 250 mg
n=6 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 250 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-6: HMPL-306 300 mg
n=4 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 300 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-8: HMPL-306 400 mg
n=5 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 400 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Parts 1 and 2: Time to Peak Plasma Concentration (Tmax) of HMPL-306
Cycle 1 Day 1
|
2.92 hour
Interval 2.15 to 3.0
|
2.17 hour
Interval 2.02 to 2.17
|
1.97 hour
Interval 1.0 to 3.08
|
2.12 hour
Interval 1.15 to 3.02
|
2.55 hour
Interval 1.0 to 4.22
|
2.20 hour
Interval 1.07 to 3.02
|
2.92 hour
Interval 2.03 to 6.0
|
2.90 hour
Interval 2.0 to 3.02
|
|
Parts 1 and 2: Time to Peak Plasma Concentration (Tmax) of HMPL-306
Cycle 2 Day 1
|
2.00 hour
Interval 1.0 to 3.0
|
2.12 hour
Interval 2.1 to 2.13
|
1.10 hour
Interval 1.0 to 4.17
|
2.05 hour
Interval 1.08 to 4.08
|
1.17 hour
Interval 0.533 to 3.15
|
2.97 hour
Interval 0.983 to 3.75
|
2.00 hour
Interval 1.03 to 3.0
|
1.96 hour
Interval 1.03 to 3.05
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8 and 24 hours post-dose on Day 1 of Cycles 1 and 2 for Part 1Population: The PK parameters analysis set included all patients who received at least 1 dose of the study drug and had a sufficient PK profile to derive at least 1 PK parameter. Only those patients with data collected at specified timepoints are reported. Due to early study termination, Part 2 was never initiated.
Blood samples were collected at the specified timepoints to determine AUC0-24 of HMPL-306.
Outcome measures
| Measure |
Part 1: Cohort-7: HMPL-306 350 mg
n=3 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 350 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohorts-1 to 8: HMPL-306
n=2 Participants
All patients enrolled in the dose escalation part (Part 1: Cohorts-1 to 8) were included in this arm.
|
Part 1: Cohort-2: HMPL-306 100 mg
n=3 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 100 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-3: HMPL-306 150 mg
n=5 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 150 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-4: HMPL-306 200 mg
n=10 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 200 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-5: HMPL-306 250 mg
n=5 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 250 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-6: HMPL-306 300 mg
n=3 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 300 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-8: HMPL-306 400 mg
n=5 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 400 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Parts 1 and 2: Area Under the Plasma Concentration-Time Curve From 0 to 24 Hours (AUC0-24) of HMPL-306
Cycle 1 Day 1
|
7556 hour*ng/mL
Geometric Coefficient of Variation 24.5
|
1625 hour*ng/mL
Geometric Coefficient of Variation 19.5
|
2894 hour*ng/mL
Geometric Coefficient of Variation 31.4
|
3084 hour*ng/mL
Geometric Coefficient of Variation 21.3
|
5007 hour*ng/mL
Geometric Coefficient of Variation 36.0
|
5045 hour*ng/mL
Geometric Coefficient of Variation 33.9
|
8315 hour*ng/mL
Geometric Coefficient of Variation 52.8
|
9712 hour*ng/mL
Geometric Coefficient of Variation 37.5
|
|
Parts 1 and 2: Area Under the Plasma Concentration-Time Curve From 0 to 24 Hours (AUC0-24) of HMPL-306
Cycle 2 Day 1
|
28342 hour*ng/mL
Geometric Coefficient of Variation 36.9
|
7033 hour*ng/mL
Geometric Coefficient of Variation 65.9
|
12907 hour*ng/mL
Geometric Coefficient of Variation 30.7
|
16710 hour*ng/mL
Geometric Coefficient of Variation 12.3
|
27427 hour*ng/mL
Geometric Coefficient of Variation 26.2
|
26616 hour*ng/mL
Geometric Coefficient of Variation 24.5
|
38461 hour*ng/mL
Geometric Coefficient of Variation 64.6
|
58900 hour*ng/mL
Geometric Coefficient of Variation 48.5
|
SECONDARY outcome
Timeframe: From screening (Day -28) until end of treatment, approximately 42 months for Part 1Population: The PD analysis set included all patients with at least 1 quantifiable level of 2-HG in plasma. Due to early study termination, Part 2 was never initiated.
Blood samples were collected at the specified timepoints to determine plasma concentrations of 2-HG which was a PD marker. The maximum inhibition rate of 2-HG for patients in different dose groups is presented.
Outcome measures
| Measure |
Part 1: Cohort-7: HMPL-306 350 mg
n=2 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 350 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohorts-1 to 8: HMPL-306
n=2 Participants
All patients enrolled in the dose escalation part (Part 1: Cohorts-1 to 8) were included in this arm.
|
Part 1: Cohort-2: HMPL-306 100 mg
n=2 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 100 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-3: HMPL-306 150 mg
n=4 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 150 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-4: HMPL-306 200 mg
n=5 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 200 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-5: HMPL-306 250 mg
n=2 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 250 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-6: HMPL-306 300 mg
n=2 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 300 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-8: HMPL-306 400 mg
n=2 Participants
Patients with locally advanced or metastatic solid tumors received HMPL-306 400 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Parts 1 and 2: Maximum Inhibition Rate of Plasma 2-Hydroxyglutaric Acid (2-HG)
|
83.22 percentage of inhibition
Standard Deviation 11.03
|
39.04 percentage of inhibition
Standard Deviation 17.73
|
69.15 percentage of inhibition
Standard Deviation 3.52
|
76.93 percentage of inhibition
Standard Deviation 17.17
|
80.79 percentage of inhibition
Standard Deviation 12.54
|
53.83 percentage of inhibition
Standard Deviation 6.68
|
95.74 percentage of inhibition
Standard Deviation 4.45
|
87.33 percentage of inhibition
Standard Deviation 6.29
|
Adverse Events
Part 1: Cohort-1: HMPL-306 50 mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1: Cohort-2: HMPL-306 100 mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1: Cohort-3: HMPL-306 150 mg
Serious events: 2 serious events
Other events: 4 other events
Deaths: 1 deaths
Part 1: Cohort-4: HMPL-306 200 mg
Serious events: 1 serious events
Other events: 11 other events
Deaths: 1 deaths
Part 1: Cohort-5: HMPL-306 250 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 2 deaths
Part 1: Cohort-6: HMPL-306 300 mg
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 1: Cohort-7: HMPL-306 350 mg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 1: Cohort-8: HMPL-306 400 mg
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part 1: Cohort-1: HMPL-306 50 mg
n=3 participants at risk
Patients with locally advanced or metastatic solid tumors received HMPL-306 50 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-2: HMPL-306 100 mg
n=3 participants at risk
Patients with locally advanced or metastatic solid tumors received HMPL-306 100 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-3: HMPL-306 150 mg
n=5 participants at risk
Patients with locally advanced or metastatic solid tumors received HMPL-306 150 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-4: HMPL-306 200 mg
n=12 participants at risk
Patients with locally advanced or metastatic solid tumors received HMPL-306 200 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-5: HMPL-306 250 mg
n=6 participants at risk
Patients with locally advanced or metastatic solid tumors received HMPL-306 250 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-6: HMPL-306 300 mg
n=4 participants at risk
Patients with locally advanced or metastatic solid tumors received HMPL-306 300 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-7: HMPL-306 350 mg
n=4 participants at risk
Patients with locally advanced or metastatic solid tumors received HMPL-306 350 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-8: HMPL-306 400 mg
n=5 participants at risk
Patients with locally advanced or metastatic solid tumors received HMPL-306 400 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Bacteraemia
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Infections and infestations
Device related infection
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Infections and infestations
Wound infection
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm swelling
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
Other adverse events
| Measure |
Part 1: Cohort-1: HMPL-306 50 mg
n=3 participants at risk
Patients with locally advanced or metastatic solid tumors received HMPL-306 50 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-2: HMPL-306 100 mg
n=3 participants at risk
Patients with locally advanced or metastatic solid tumors received HMPL-306 100 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-3: HMPL-306 150 mg
n=5 participants at risk
Patients with locally advanced or metastatic solid tumors received HMPL-306 150 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-4: HMPL-306 200 mg
n=12 participants at risk
Patients with locally advanced or metastatic solid tumors received HMPL-306 200 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-5: HMPL-306 250 mg
n=6 participants at risk
Patients with locally advanced or metastatic solid tumors received HMPL-306 250 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-6: HMPL-306 300 mg
n=4 participants at risk
Patients with locally advanced or metastatic solid tumors received HMPL-306 300 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-7: HMPL-306 350 mg
n=4 participants at risk
Patients with locally advanced or metastatic solid tumors received HMPL-306 350 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
Part 1: Cohort-8: HMPL-306 400 mg
n=5 participants at risk
Patients with locally advanced or metastatic solid tumors received HMPL-306 400 mg tablet orally QD in a 28-day continuous dosing treatment cycle until Pd, initiation of new anticancer therapy, withdrawal of consent, lost to follow-up, death, or the end of the study, whichever came first. Each cycle duration was 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
16.7%
1/6 • Number of events 3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
50.0%
2/4 • Number of events 2 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
50.0%
2/4 • Number of events 2 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
16.7%
2/12 • Number of events 2 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
33.3%
2/6 • Number of events 2 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
25.0%
1/4 • Number of events 2 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
50.0%
2/4 • Number of events 2 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
20.0%
1/5 • Number of events 3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
33.3%
2/6 • Number of events 2 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Gastrointestinal disorders
Abdominal distension
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Gastrointestinal disorders
Rectal tenesmus
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Investigations
Amylase increased
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
20.0%
1/5 • Number of events 2 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
25.0%
1/4 • Number of events 6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
50.0%
2/4 • Number of events 2 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Investigations
International normalised ratio increased
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
16.7%
2/12 • Number of events 2 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Investigations
Weight decreased
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Investigations
White blood cell count decreased
|
33.3%
1/3 • Number of events 2 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
16.7%
1/6 • Number of events 2 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Investigations
Blood alkaline phosphatase increased
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Investigations
Blood calcium increased
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Investigations
Blood creatine phosphokinase decreased
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Investigations
Lipase increased
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
16.7%
1/6 • Number of events 2 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Investigations
Weight increased
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
25.0%
1/4 • Number of events 2 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
25.0%
1/4 • Number of events 2 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
40.0%
2/5 • Number of events 5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
16.7%
2/12 • Number of events 2 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
16.7%
1/6 • Number of events 3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
8.3%
1/12 • Number of events 2 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
20.0%
1/5 • Number of events 2 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
16.7%
2/12 • Number of events 3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
25.0%
1/4 • Number of events 2 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
20.0%
1/5 • Number of events 2 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
20.0%
1/5 • Number of events 2 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Nervous system disorders
Hemiplegia
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Nervous system disorders
Seizure
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
General disorders
Asthenia
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
25.0%
3/12 • Number of events 3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
25.0%
1/4 • Number of events 2 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
40.0%
2/5 • Number of events 3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
General disorders
Fatigue
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
General disorders
Feeling abnormal
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
General disorders
Gait disturbance
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
20.0%
1/5 • Number of events 2 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
General disorders
Physical deconditioning
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
General disorders
Pyrexia
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
50.0%
2/4 • Number of events 2 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Musculoskeletal and connective tissue disorders
Locomotive syndrome
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
33.3%
1/3 • Number of events 2 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
25.0%
1/4 • Number of events 2 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
50.0%
2/4 • Number of events 2 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Blood and lymphatic system disorders
Neutrophilia
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Infections and infestations
COVID-19
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Skin and subcutaneous tissue disorders
Skin plaque
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive sleep apnoea syndrome
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Vascular disorders
Axillary vein thrombosis
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Vascular disorders
Flushing
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Vascular disorders
Haematoma
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Vascular disorders
Hot flush
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Psychiatric disorders
Affect lability
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Eye disorders
Photophobia
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Eye disorders
Subretinal fluid
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/6 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/3 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/12 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/4 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
0.00%
0/5 • Adverse events were collected from the from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 43 months for Part 1. All-cause mortality (deaths) was collected from the first dose of study drug (Day 1) up to end of follow-up, approximately 47 months.
The safety analysis set included all enrolled patients who received at least 1 dose of study drug. Due to early study termination, Part 2 was never initiated.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place