Trial Outcomes & Findings for To Evaluate the Efficacy and Safety of Tislelizumab in Combination With Lenvatinib in Participants With Selected Solid Tumors (NCT NCT05014828)
NCT ID: NCT05014828
Last Updated: 2025-08-24
Results Overview
An adverse event refers to any unintended or unfavorable sign, symptom, or condition (including abnormal lab results) that occurs during the study, regardless of whether it is related to the study drug. A serious adverse event (SAE) is any untoward medical occurrence that, at any dose: * Resulted in death * Was life-threatening * Required hospitalization or prolongation of existing hospitalization * Resulted in disability/incapacity * Was a congenital anomaly/birth defect * Was considered a significant medical AE by the investigator based on medical judgement. A dose-limiting toxicity (DLT) was defined as a Grade 3 or 4 hematologic or nonhematologic toxicity occurring during the DLT assessment window and deemed related to one or more study drugs by the investigator.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
58 participants
Primary outcome timeframe
From first dose through the end of the safety run-in part, up to 124 days; The DLT observation period was 28 days after first dose.
Results posted on
2025-08-24
Participant Flow
Participants were enrolled in multiple study centers in China. The first participant dosed was on September 18th, 2021 and the last participant completed on July 10th, 2024. Enrollment began with a run-in phase to assess the safety and tolerability of tislelizumab plus lenvatinib combination therapy. Once the Safety Monitoring Committee confirmed that the combination therapy was tolerable, enrollment into the expansion phase began.
This study included a safety run-in and expansion phase to evaluate treatment with tislelizumab plus lenvatinib. All participants enrolled in the run-in phase continued into the expansion phase and all participants received the same treatment dose. According to the planned analysis, all enrolled participants were analyzed together (including those who enrolled in the run-in phase) based on tumor type.
Participant milestones
| Measure |
Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Participants with previously untreated, advanced or metastatic SCCHN received tislelizumab (400 mg administered intravenously \[IV\] every 6 weeks \[Q6W\]) in combination with lenvatinib (20 mg taken orally once daily \[QD\]) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination.
|
Renal Cell Carcinoma (RCC)
Systemic therapy naive participants with advanced or metastatic RCC received tislelizumab (400 mg IV Q6W) plus lenvatinib (20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination
|
Non-Small Cell Lung Cancer (NSCLC)
Participants with NSCLC expressing programmed cell death-ligand 1 (PD-L1) in ≥1% of tumor cells (TC ≥1%) and who had not received prior systemic therapy received tislelizumab (400 mg IV Q6W) and lenvatinib (20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination.
|
Gastric Cancer (GC)
Participants with advanced GC who had received one prior line of systemic therapy were enrolled to receive tislelizumab and lenvatinib at the RP2D (tislelizumab 400 mg IV Q6W; lenvatinib 20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination; this cohort was closed early due to changes in the first-line standard of care.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
27
|
23
|
5
|
3
|
|
Overall Study
Treated
|
27
|
23
|
5
|
3
|
|
Overall Study
Enrolled in Safety Run-in Stage
|
2
|
0
|
5
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
27
|
23
|
5
|
3
|
Reasons for withdrawal
| Measure |
Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Participants with previously untreated, advanced or metastatic SCCHN received tislelizumab (400 mg administered intravenously \[IV\] every 6 weeks \[Q6W\]) in combination with lenvatinib (20 mg taken orally once daily \[QD\]) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination.
|
Renal Cell Carcinoma (RCC)
Systemic therapy naive participants with advanced or metastatic RCC received tislelizumab (400 mg IV Q6W) plus lenvatinib (20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination
|
Non-Small Cell Lung Cancer (NSCLC)
Participants with NSCLC expressing programmed cell death-ligand 1 (PD-L1) in ≥1% of tumor cells (TC ≥1%) and who had not received prior systemic therapy received tislelizumab (400 mg IV Q6W) and lenvatinib (20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination.
|
Gastric Cancer (GC)
Participants with advanced GC who had received one prior line of systemic therapy were enrolled to receive tislelizumab and lenvatinib at the RP2D (tislelizumab 400 mg IV Q6W; lenvatinib 20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination; this cohort was closed early due to changes in the first-line standard of care.
|
|---|---|---|---|---|
|
Overall Study
Study Completed by Sponsor
|
16
|
16
|
3
|
3
|
|
Overall Study
Death
|
11
|
6
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
2
|
0
|
|
Overall Study
Miscellaneous.
|
0
|
1
|
0
|
0
|
Baseline Characteristics
To Evaluate the Efficacy and Safety of Tislelizumab in Combination With Lenvatinib in Participants With Selected Solid Tumors
Baseline characteristics by cohort
| Measure |
Squamous Cell Carcinoma of the Head and Neck (SCCHN)
n=27 Participants
Participants with previously untreated, advanced or metastatic SCCHN received tislelizumab (400 mg administered intravenously \[IV\] every 6 weeks \[Q6W\]) in combination with lenvatinib (20 mg taken orally once daily \[QD\]) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination.
|
Renal Cell Carcinoma (RCC)
n=23 Participants
Systemic therapy naive participants with advanced or metastatic RCC received tislelizumab (400 mg IV Q6W) plus lenvatinib (20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination
|
Non-Small Cell Lung Cancer (NSCLC)
n=5 Participants
Participants with NSCLC expressing programmed cell death-ligand 1 (PD-L1) in ≥1% of tumor cells (TC ≥1%) and who had not received prior systemic therapy received tislelizumab (400 mg IV Q6W) and lenvatinib (20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination; this cohort was closed early based on emerging external data.
|
Gastric Cancer (GC)
n=3 Participants
Participants with advanced GC who had received one prior line of systemic therapy were enrolled to receive tislelizumab and lenvatinib at the RP2D (tislelizumab 400 mg IV Q6W; lenvatinib 20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination; this cohort was closed early due to changes in the first-line standard of care.
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
61.9 years
STANDARD_DEVIATION 10.14 • n=5 Participants
|
62.3 years
STANDARD_DEVIATION 7.38 • n=7 Participants
|
65.6 years
STANDARD_DEVIATION 7.92 • n=5 Participants
|
61.3 years
STANDARD_DEVIATION 9.29 • n=4 Participants
|
62.3 years
STANDARD_DEVIATION 8.75 • n=21 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
27 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
58 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: From first dose through the end of the safety run-in part, up to 124 days; The DLT observation period was 28 days after first dose.Population: The Safety run-in set is defined as all participants in the safety run-in stage.
An adverse event refers to any unintended or unfavorable sign, symptom, or condition (including abnormal lab results) that occurs during the study, regardless of whether it is related to the study drug. A serious adverse event (SAE) is any untoward medical occurrence that, at any dose: * Resulted in death * Was life-threatening * Required hospitalization or prolongation of existing hospitalization * Resulted in disability/incapacity * Was a congenital anomaly/birth defect * Was considered a significant medical AE by the investigator based on medical judgement. A dose-limiting toxicity (DLT) was defined as a Grade 3 or 4 hematologic or nonhematologic toxicity occurring during the DLT assessment window and deemed related to one or more study drugs by the investigator.
Outcome measures
| Measure |
Safety Run-In
n=7 Participants
Participants with advanced or metastatic unresectable solid tumors were enrolled to receive 400 mg of tislelizumab administered on Day 1 of each 6-week cycle, along with 20 mg of lenvatinib self-administered orally once daily, to determine the recommended Part 2 dose (RP2D).
|
Renal Cell Carcinoma (RCC)
Systemic therapy naive participants with advanced or metastatic RCC received tislelizumab (400 mg IV Q6W) plus lenvatinib (20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination.
|
Non-Small Cell Lung Cancer (NSCLC)
Participants with NSCLC expressing programmed cell death-ligand 1 (PD-L1) in ≥1% of tumor cells (TC ≥1%) and who had not received prior systemic therapy received tislelizumab (400 mg IV Q6W) and lenvatinib (20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination; this cohort was closed early based on emerging external data.
|
Gastric Cancer (GC)
Participants with advanced GC who had received one prior line of systemic therapy were enrolled to receive tislelizumab and lenvatinib at the RP2D (tislelizumab 400 mg IV Q6W; lenvatinib 20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination; this cohort was closed early due to changes in the first-line standard of care.
|
|---|---|---|---|---|
|
Safety Run-in: Number of Participants With Adverse Events (AEs)
Number of Participants with any TEAEs
|
6 Participants
|
—
|
—
|
—
|
|
Safety Run-in: Number of Participants With Adverse Events (AEs)
Number of Participants with any SAEs
|
4 Participants
|
—
|
—
|
—
|
|
Safety Run-in: Number of Participants With Adverse Events (AEs)
Number of Participants with any DLTs
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From the first dose up to the primary analysis data cut-off date of 10 October 2023 (maximum time on study was 24.7 months)Population: Safety Analysis Set: Participants who received ≥ 1 dose of study drug(s) Evaluable Analysis Set: Participants who received ≥ 1 dose of study drug(s), have evaluable disease at baseline, and have ≥ 1 evaluable postbaseline tumor response assessment unless any clinical progressive disease or death occurred before the first postbaseline tumor assessment.
Overall response rate is defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 Tumor assessments. CR is defined as the disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Safety Run-In
n=27 Participants
Participants with advanced or metastatic unresectable solid tumors were enrolled to receive 400 mg of tislelizumab administered on Day 1 of each 6-week cycle, along with 20 mg of lenvatinib self-administered orally once daily, to determine the recommended Part 2 dose (RP2D).
|
Renal Cell Carcinoma (RCC)
n=23 Participants
Systemic therapy naive participants with advanced or metastatic RCC received tislelizumab (400 mg IV Q6W) plus lenvatinib (20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination.
|
Non-Small Cell Lung Cancer (NSCLC)
n=5 Participants
Participants with NSCLC expressing programmed cell death-ligand 1 (PD-L1) in ≥1% of tumor cells (TC ≥1%) and who had not received prior systemic therapy received tislelizumab (400 mg IV Q6W) and lenvatinib (20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination; this cohort was closed early based on emerging external data.
|
Gastric Cancer (GC)
n=3 Participants
Participants with advanced GC who had received one prior line of systemic therapy were enrolled to receive tislelizumab and lenvatinib at the RP2D (tislelizumab 400 mg IV Q6W; lenvatinib 20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination; this cohort was closed early due to changes in the first-line standard of care.
|
|---|---|---|---|---|
|
Overall Response Rate (ORR)
Safety Analysis Set
|
29.6 Percentage of participants
Interval 13.8 to 50.2
|
60.9 Percentage of participants
Interval 38.5 to 80.3
|
20.0 Percentage of participants
Interval 0.5 to 71.6
|
33.3 Percentage of participants
Interval 0.8 to 90.6
|
|
Overall Response Rate (ORR)
Evaluable Analysis Set
|
33.3 Percentage of participants
Interval 15.6 to 55.3
|
66.7 Percentage of participants
Interval 43.0 to 85.4
|
20.0 Percentage of participants
Interval 0.5 to 71.6
|
33.3 Percentage of participants
Interval 0.8 to 90.6
|
SECONDARY outcome
Timeframe: From the first dose up to the primary analysis data cut-off date of 10 October 2023 (maximum time on study was 24.7 months)Population: Safety analysis set
PFS was defined as the time from randomization to the first objectively documented disease progression as assessed by the investigator per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) or death from any cause, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Safety Run-In
n=27 Participants
Participants with advanced or metastatic unresectable solid tumors were enrolled to receive 400 mg of tislelizumab administered on Day 1 of each 6-week cycle, along with 20 mg of lenvatinib self-administered orally once daily, to determine the recommended Part 2 dose (RP2D).
|
Renal Cell Carcinoma (RCC)
n=23 Participants
Systemic therapy naive participants with advanced or metastatic RCC received tislelizumab (400 mg IV Q6W) plus lenvatinib (20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination.
|
Non-Small Cell Lung Cancer (NSCLC)
n=5 Participants
Participants with NSCLC expressing programmed cell death-ligand 1 (PD-L1) in ≥1% of tumor cells (TC ≥1%) and who had not received prior systemic therapy received tislelizumab (400 mg IV Q6W) and lenvatinib (20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination; this cohort was closed early based on emerging external data.
|
Gastric Cancer (GC)
n=3 Participants
Participants with advanced GC who had received one prior line of systemic therapy were enrolled to receive tislelizumab and lenvatinib at the RP2D (tislelizumab 400 mg IV Q6W; lenvatinib 20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination; this cohort was closed early due to changes in the first-line standard of care.
|
|---|---|---|---|---|
|
Progression Free Survival (PFS)
|
6.1 Months
Interval 4.3 to 13.7
|
15.4 Months
Interval 8.4 to
Not estimable due to insufficient number of participants with events
|
6.0 Months
Interval 2.5 to
Not estimable due to insufficient number of participants with events
|
NA Months
Interval 1.4 to
Not estimable due to insufficient number of participants with events
|
SECONDARY outcome
Timeframe: From the first dose up to the primary analysis data cut-off date of 10 October 2023 (maximum time on study was 24.7 months)Population: Evaluable Analysis Set. Only participants with best overall response of complete response or partial response confirmed per RECIST v1.1 were included in this analysis,
DOR was defined as the time from the first documented objective response to documented radiological disease progression as assessed by the investigator using RECIST v1.1, or death from any cause, whichever occurred first. Median DOR was estimated using the Kaplan-Meier method. Progressive disease is captured as at least a 20% increase in the sum of diameters of target lesions, using the smallest sum on study as the reference (including the baseline sum if it was the smallest). In addition to the 20% relative increase, the sum also had to show an absolute increase of at least 5 mm.
Outcome measures
| Measure |
Safety Run-In
n=8 Participants
Participants with advanced or metastatic unresectable solid tumors were enrolled to receive 400 mg of tislelizumab administered on Day 1 of each 6-week cycle, along with 20 mg of lenvatinib self-administered orally once daily, to determine the recommended Part 2 dose (RP2D).
|
Renal Cell Carcinoma (RCC)
n=14 Participants
Systemic therapy naive participants with advanced or metastatic RCC received tislelizumab (400 mg IV Q6W) plus lenvatinib (20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination.
|
Non-Small Cell Lung Cancer (NSCLC)
n=1 Participants
Participants with NSCLC expressing programmed cell death-ligand 1 (PD-L1) in ≥1% of tumor cells (TC ≥1%) and who had not received prior systemic therapy received tislelizumab (400 mg IV Q6W) and lenvatinib (20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination; this cohort was closed early based on emerging external data.
|
Gastric Cancer (GC)
n=1 Participants
Participants with advanced GC who had received one prior line of systemic therapy were enrolled to receive tislelizumab and lenvatinib at the RP2D (tislelizumab 400 mg IV Q6W; lenvatinib 20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination; this cohort was closed early due to changes in the first-line standard of care.
|
|---|---|---|---|---|
|
Duration of Response (DOR)
|
9.6 Months
Interval 2.8 to
Not estimable due to insufficient number of participants with events
|
NA Months
Interval 10.8 to
Not estimable due to insufficient number of participants with events
|
18.5 Months
Not estimable for sample size = 1
|
NA Months
Not estimable due to insufficient number of participants with events and sample size of 1.
|
SECONDARY outcome
Timeframe: From the first dose up to the primary analysis data cut-off date of 10 October 2023 (maximum time on study was 24.7 months)Population: Evaluable analysis set and Safety Analysis Set
DCR was defined as the percentage of participants who demonstrated a confirmed complete response (CR), partial response (PR), or stable disease (SD) as the best overall response, in accordance with the RECIST version 1.1 criteria. CR was defined as the disappearance of all target and non-target lesions with no new lesions observed. Any pathological lymph nodes (whether target or non-target) were required to have a reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum of diameters as the reference. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), using the smallest sum of diameters recorded while on study as the reference.
Outcome measures
| Measure |
Safety Run-In
n=27 Participants
Participants with advanced or metastatic unresectable solid tumors were enrolled to receive 400 mg of tislelizumab administered on Day 1 of each 6-week cycle, along with 20 mg of lenvatinib self-administered orally once daily, to determine the recommended Part 2 dose (RP2D).
|
Renal Cell Carcinoma (RCC)
n=23 Participants
Systemic therapy naive participants with advanced or metastatic RCC received tislelizumab (400 mg IV Q6W) plus lenvatinib (20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination.
|
Non-Small Cell Lung Cancer (NSCLC)
n=5 Participants
Participants with NSCLC expressing programmed cell death-ligand 1 (PD-L1) in ≥1% of tumor cells (TC ≥1%) and who had not received prior systemic therapy received tislelizumab (400 mg IV Q6W) and lenvatinib (20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination; this cohort was closed early based on emerging external data.
|
Gastric Cancer (GC)
n=3 Participants
Participants with advanced GC who had received one prior line of systemic therapy were enrolled to receive tislelizumab and lenvatinib at the RP2D (tislelizumab 400 mg IV Q6W; lenvatinib 20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination; this cohort was closed early due to changes in the first-line standard of care.
|
|---|---|---|---|---|
|
Disease Control Rate (DCR)
Safety Analysis Set
|
70.4 Percentage of Participants
Interval 49.8 to 86.2
|
87.0 Percentage of Participants
Interval 66.4 to 97.2
|
100.0 Percentage of Participants
Interval 47.8 to 100.0
|
66.7 Percentage of Participants
Interval 9.4 to 99.2
|
|
Disease Control Rate (DCR)
Evaluable Analysis Set
|
79.2 Percentage of Participants
Interval 57.8 to 92.9
|
95.2 Percentage of Participants
Interval 76.2 to 99.9
|
100.0 Percentage of Participants
Interval 47.8 to 100.0
|
66.7 Percentage of Participants
Interval 9.4 to 99.2
|
SECONDARY outcome
Timeframe: From the first dose up to the primary analysis data cut-off date of 10 October 2023 (maximum time on study was 24.7 months)Population: Safety Analysis Set
OS was defined as the time from randomization to the documented date of death for participants who died on or before the data cutoff date. Median OS was calculated using the Kaplan-Meier method. Data for participants who were alive at the data cutoff date were censored at their last known alive date, defined as either the clinical cutoff date for those still on treatment or the most recent available date confirming they were alive, whichever occurred first.
Outcome measures
| Measure |
Safety Run-In
n=27 Participants
Participants with advanced or metastatic unresectable solid tumors were enrolled to receive 400 mg of tislelizumab administered on Day 1 of each 6-week cycle, along with 20 mg of lenvatinib self-administered orally once daily, to determine the recommended Part 2 dose (RP2D).
|
Renal Cell Carcinoma (RCC)
n=23 Participants
Systemic therapy naive participants with advanced or metastatic RCC received tislelizumab (400 mg IV Q6W) plus lenvatinib (20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination.
|
Non-Small Cell Lung Cancer (NSCLC)
n=5 Participants
Participants with NSCLC expressing programmed cell death-ligand 1 (PD-L1) in ≥1% of tumor cells (TC ≥1%) and who had not received prior systemic therapy received tislelizumab (400 mg IV Q6W) and lenvatinib (20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination; this cohort was closed early based on emerging external data.
|
Gastric Cancer (GC)
n=3 Participants
Participants with advanced GC who had received one prior line of systemic therapy were enrolled to receive tislelizumab and lenvatinib at the RP2D (tislelizumab 400 mg IV Q6W; lenvatinib 20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination; this cohort was closed early due to changes in the first-line standard of care.
|
|---|---|---|---|---|
|
Overall Survival (OS)
|
NA Month
Interval 5.7 to
Not estimable due to insufficient number of participants with events
|
NA Month
Not estimable due to insufficient number of participants with events
|
NA Month
Not estimable due to insufficient number of participants with events
|
NA Month
Not estimable due to insufficient number of participants with events
|
SECONDARY outcome
Timeframe: From first dose of study drug to 30 days after last dose, up to the study completion date of 10 July 2024 (up to 32.5 months)Population: Safety Analysis Set
An adverse event refers to any unintended or unfavorable sign, symptom, or condition (including abnormal lab results) that occurs during the study, regardless of whether it is related to the study drug.
Outcome measures
| Measure |
Safety Run-In
n=27 Participants
Participants with advanced or metastatic unresectable solid tumors were enrolled to receive 400 mg of tislelizumab administered on Day 1 of each 6-week cycle, along with 20 mg of lenvatinib self-administered orally once daily, to determine the recommended Part 2 dose (RP2D).
|
Renal Cell Carcinoma (RCC)
n=23 Participants
Systemic therapy naive participants with advanced or metastatic RCC received tislelizumab (400 mg IV Q6W) plus lenvatinib (20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination.
|
Non-Small Cell Lung Cancer (NSCLC)
n=5 Participants
Participants with NSCLC expressing programmed cell death-ligand 1 (PD-L1) in ≥1% of tumor cells (TC ≥1%) and who had not received prior systemic therapy received tislelizumab (400 mg IV Q6W) and lenvatinib (20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination; this cohort was closed early based on emerging external data.
|
Gastric Cancer (GC)
n=3 Participants
Participants with advanced GC who had received one prior line of systemic therapy were enrolled to receive tislelizumab and lenvatinib at the RP2D (tislelizumab 400 mg IV Q6W; lenvatinib 20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination; this cohort was closed early due to changes in the first-line standard of care.
|
|---|---|---|---|---|
|
Number of Participants Experiencing Adverse Events (AEs)
Number of Participants with any TEAEs
|
27 Participants
|
22 Participants
|
5 Participants
|
3 Participants
|
|
Number of Participants Experiencing Adverse Events (AEs)
Number of Participants with any SAEs
|
17 Participants
|
11 Participants
|
2 Participants
|
2 Participants
|
Adverse Events
Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Serious events: 17 serious events
Other events: 27 other events
Deaths: 11 deaths
Renal Cell Carcinoma (RCC)
Serious events: 11 serious events
Other events: 21 other events
Deaths: 6 deaths
Non-Small Cell Lung Cancer (NSCLC)
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Gastric Cancer (GC)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Squamous Cell Carcinoma of the Head and Neck (SCCHN)
n=27 participants at risk
Participants with previously untreated, advanced or metastatic SCCHN received tislelizumab (400 mg administered intravenously \[IV\] every 6 weeks \[Q6W\]) in combination with lenvatinib (20 mg taken orally once daily \[QD\]) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination.
|
Renal Cell Carcinoma (RCC)
n=23 participants at risk
Systemic therapy naive participants with advanced or metastatic RCC received tislelizumab (400 mg IV Q6W) plus lenvatinib (20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination.
|
Non-Small Cell Lung Cancer (NSCLC)
n=5 participants at risk
Participants with NSCLC expressing programmed cell death-ligand 1 (PD-L1) in ≥1% of tumor cells (TC ≥1%) and who had not received prior systemic therapy received tislelizumab (400 mg IV Q6W) and lenvatinib (20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination; this cohort was closed early based on emerging external data.
|
Gastric Cancer (GC)
n=3 participants at risk
Participants with advanced GC who had received one prior line of systemic therapy were enrolled to receive tislelizumab and lenvatinib at the RP2D (tislelizumab 400 mg IV Q6W; lenvatinib 20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination; this cohort was closed early due to changes in the first-line standard of care.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Necrotic lymphadenopathy
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
8.7%
2/23 • Number of events 2 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Cardiac disorders
Arrhythmia
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Cardiac disorders
Cardio-respiratory arrest
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
33.3%
1/3 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Gastrointestinal disorders
Dysphagia
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Gastrointestinal disorders
Pancreatitis acute
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
General disorders
Death
|
7.4%
2/27 • Number of events 2 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
General disorders
Pyrexia
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Infections and infestations
COVID-19 pneumonia
|
7.4%
2/27 • Number of events 2 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Infections and infestations
Febrile infection
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Infections and infestations
Osteomyelitis
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Infections and infestations
Pneumonia
|
11.1%
3/27 • Number of events 3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
33.3%
1/3 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
33.3%
1/3 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
20.0%
1/5 • Number of events 2 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Metabolism and nutrition disorders
Malnutrition
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemorrhagic tumour necrosis
|
3.7%
1/27 • Number of events 3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Nervous system disorders
Cerebral infarction
|
3.7%
1/27 • Number of events 2 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Psychiatric disorders
Depression
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
20.0%
1/5 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated lung disease
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Vascular disorders
Arterial haemorrhage
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Vascular disorders
Hypertension
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
Other adverse events
| Measure |
Squamous Cell Carcinoma of the Head and Neck (SCCHN)
n=27 participants at risk
Participants with previously untreated, advanced or metastatic SCCHN received tislelizumab (400 mg administered intravenously \[IV\] every 6 weeks \[Q6W\]) in combination with lenvatinib (20 mg taken orally once daily \[QD\]) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination.
|
Renal Cell Carcinoma (RCC)
n=23 participants at risk
Systemic therapy naive participants with advanced or metastatic RCC received tislelizumab (400 mg IV Q6W) plus lenvatinib (20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination.
|
Non-Small Cell Lung Cancer (NSCLC)
n=5 participants at risk
Participants with NSCLC expressing programmed cell death-ligand 1 (PD-L1) in ≥1% of tumor cells (TC ≥1%) and who had not received prior systemic therapy received tislelizumab (400 mg IV Q6W) and lenvatinib (20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination; this cohort was closed early based on emerging external data.
|
Gastric Cancer (GC)
n=3 participants at risk
Participants with advanced GC who had received one prior line of systemic therapy were enrolled to receive tislelizumab and lenvatinib at the RP2D (tislelizumab 400 mg IV Q6W; lenvatinib 20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination; this cohort was closed early due to changes in the first-line standard of care.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Toothache
|
3.7%
1/27 • Number of events 2 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 2 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
3/27 • Number of events 3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
33.3%
1/3 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
General disorders
Asthenia
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
26.1%
6/23 • Number of events 6 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
33.3%
1/3 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Blood and lymphatic system disorders
Anaemia
|
25.9%
7/27 • Number of events 8 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
21.7%
5/23 • Number of events 5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
20.0%
1/5 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Blood and lymphatic system disorders
Hypercoagulation
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
13.0%
3/23 • Number of events 4 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
17.4%
4/23 • Number of events 6 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 2 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Cardiac disorders
Cardiac discomfort
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
33.3%
1/3 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Cardiac disorders
Palpitations
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Cardiac disorders
Sinus arrhythmia
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 2 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Cardiac disorders
Sinus bradycardia
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
8.7%
2/23 • Number of events 5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
33.3%
1/3 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Cardiac disorders
Tachycardia
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Ear and labyrinth disorders
Tinnitus
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Endocrine disorders
Hyperthyroidism
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
8.7%
2/23 • Number of events 2 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Endocrine disorders
Hypothyroidism
|
37.0%
10/27 • Number of events 16 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
69.6%
16/23 • Number of events 23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
60.0%
3/5 • Number of events 3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
33.3%
1/3 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Gastrointestinal disorders
Abdominal distension
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
13.0%
3/23 • Number of events 4 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Gastrointestinal disorders
Abdominal pain
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
8.7%
2/23 • Number of events 3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.4%
2/27 • Number of events 6 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
8.7%
2/23 • Number of events 2 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Gastrointestinal disorders
Alveolar bone defect
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Gastrointestinal disorders
Anal fissure
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Gastrointestinal disorders
Aphthous ulcer
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Gastrointestinal disorders
Chronic gastritis
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Gastrointestinal disorders
Constipation
|
11.1%
3/27 • Number of events 3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
33.3%
1/3 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Gastrointestinal disorders
Diarrhoea
|
18.5%
5/27 • Number of events 8 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
21.7%
5/23 • Number of events 5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
40.0%
2/5 • Number of events 2 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Gastrointestinal disorders
Dysphagia
|
11.1%
3/27 • Number of events 3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.7%
1/27 • Number of events 2 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
General disorders
Face oedema
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
13.0%
3/23 • Number of events 3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Gastrointestinal disorders
Gingival erosion
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Gastrointestinal disorders
Gingival pain
|
7.4%
2/27 • Number of events 2 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
8.7%
2/23 • Number of events 2 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Gastrointestinal disorders
Gingival swelling
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 2 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Gastrointestinal disorders
Loose tooth
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Gastrointestinal disorders
Mouth ulceration
|
25.9%
7/27 • Number of events 11 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
13.0%
3/23 • Number of events 4 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
20.0%
1/5 • Number of events 2 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Gastrointestinal disorders
Nausea
|
7.4%
2/27 • Number of events 3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
8.7%
2/23 • Number of events 2 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
11.1%
3/27 • Number of events 4 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Gastrointestinal disorders
Oral disorder
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Gastrointestinal disorders
Oral pain
|
7.4%
2/27 • Number of events 2 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Gastrointestinal disorders
Stomatitis
|
14.8%
4/27 • Number of events 4 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
8.7%
2/23 • Number of events 2 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
20.0%
1/5 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Gastrointestinal disorders
Tooth loss
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
General disorders
Facial pain
|
7.4%
2/27 • Number of events 2 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
General disorders
Fatigue
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
General disorders
Generalised oedema
|
7.4%
2/27 • Number of events 2 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
General disorders
Influenza like illness
|
3.7%
1/27 • Number of events 2 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
8.7%
2/23 • Number of events 2 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
General disorders
Localised oedema
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
General disorders
Malaise
|
11.1%
3/27 • Number of events 4 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
20.0%
1/5 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
33.3%
1/3 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
General disorders
Oedema peripheral
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
13.0%
3/23 • Number of events 4 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
20.0%
1/5 • Number of events 2 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
General disorders
Pain
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
General disorders
Pyrexia
|
18.5%
5/27 • Number of events 6 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
17.4%
4/23 • Number of events 6 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
20.0%
1/5 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
8.7%
2/23 • Number of events 3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Infections and infestations
Asymptomatic bacteriuria
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
8.7%
2/23 • Number of events 3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Infections and infestations
COVID-19
|
14.8%
4/27 • Number of events 4 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
43.5%
10/23 • Number of events 12 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Infections and infestations
Fascial infection
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Infections and infestations
Gingivitis
|
3.7%
1/27 • Number of events 2 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
8.7%
2/23 • Number of events 2 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
33.3%
1/3 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Infections and infestations
Herpes zoster
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Infections and infestations
Hordeolum
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
20.0%
1/5 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Infections and infestations
Influenza
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
8.7%
2/23 • Number of events 2 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Infections and infestations
Laryngitis
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Infections and infestations
Laryngopharyngitis
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
8.7%
2/23 • Number of events 2 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Infections and infestations
Periodontitis
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Infections and infestations
Pneumonia
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
20.0%
1/5 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Infections and infestations
Rhinitis
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Infections and infestations
Upper respiratory tract infection
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
40.0%
2/5 • Number of events 4 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Infections and infestations
Urinary tract infection
|
11.1%
3/27 • Number of events 3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
13.0%
3/23 • Number of events 3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Injury, poisoning and procedural complications
Anal injury
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Injury, poisoning and procedural complications
Head injury
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Injury, poisoning and procedural complications
Lip injury
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Investigations
Alanine aminotransferase increased
|
14.8%
4/27 • Number of events 4 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
21.7%
5/23 • Number of events 6 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Investigations
Amylase increased
|
7.4%
2/27 • Number of events 2 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
26.1%
6/23 • Number of events 9 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Investigations
Aspartate aminotransferase increased
|
18.5%
5/27 • Number of events 5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
17.4%
4/23 • Number of events 6 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Investigations
Bile acids increased
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Investigations
Bilirubin conjugated decreased
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Investigations
Blood alkaline phosphatase increased
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 2 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Investigations
Blood bilirubin increased
|
11.1%
3/27 • Number of events 4 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
30.4%
7/23 • Number of events 18 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Investigations
Blood cholesterol increased
|
7.4%
2/27 • Number of events 3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Investigations
Blood corticotrophin decreased
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Investigations
Blood creatine phosphokinase MB increased
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
8.7%
2/23 • Number of events 4 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
8.7%
2/23 • Number of events 3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Investigations
Blood creatinine increased
|
7.4%
2/27 • Number of events 3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
21.7%
5/23 • Number of events 6 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
33.3%
1/3 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Investigations
Blood glucose increased
|
3.7%
1/27 • Number of events 4 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 2 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Investigations
Blood thyroid stimulating hormone increased
|
7.4%
2/27 • Number of events 2 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
17.4%
4/23 • Number of events 4 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Investigations
Blood urea increased
|
7.4%
2/27 • Number of events 2 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 2 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Investigations
Blood uric acid increased
|
7.4%
2/27 • Number of events 3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Investigations
C-reactive protein increased
|
3.7%
1/27 • Number of events 3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Investigations
Eosinophil count increased
|
3.7%
1/27 • Number of events 2 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Investigations
Gamma-glutamyltransferase increased
|
11.1%
3/27 • Number of events 3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
8.7%
2/23 • Number of events 3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Investigations
Granulocyte count increased
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Investigations
Hepatobiliary scan abnormal
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Investigations
Lipase increased
|
14.8%
4/27 • Number of events 5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
30.4%
7/23 • Number of events 9 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
33.3%
1/3 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Investigations
Lymphocyte count decreased
|
7.4%
2/27 • Number of events 2 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
13.0%
3/23 • Number of events 5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Investigations
Neutrophil count decreased
|
3.7%
1/27 • Number of events 4 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
8.7%
2/23 • Number of events 3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Investigations
Platelet count decreased
|
7.4%
2/27 • Number of events 2 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
34.8%
8/23 • Number of events 9 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Investigations
Protein urine present
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
34.8%
8/23 • Number of events 14 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Investigations
SARS-CoV-2 test positive
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Investigations
Troponin I increased
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
8.7%
2/23 • Number of events 3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Investigations
Troponin T increased
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
8.7%
2/23 • Number of events 3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Investigations
Urine ketone body present
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Investigations
Weight decreased
|
48.1%
13/27 • Number of events 13 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
56.5%
13/23 • Number of events 15 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
20.0%
1/5 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Investigations
White blood cell count decreased
|
3.7%
1/27 • Number of events 4 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
17.4%
4/23 • Number of events 6 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Investigations
White blood cell count increased
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
22.2%
6/27 • Number of events 7 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
34.8%
8/23 • Number of events 8 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
20.0%
1/5 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
33.3%
1/3 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
14.8%
4/27 • Number of events 4 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
8.7%
2/23 • Number of events 2 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
3.7%
1/27 • Number of events 2 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
3.7%
1/27 • Number of events 2 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
26.1%
6/23 • Number of events 7 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
17.4%
4/23 • Number of events 6 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
20.0%
1/5 • Number of events 2 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
17.4%
4/23 • Number of events 14 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
33.3%
1/3 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
7.4%
2/27 • Number of events 2 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
30.4%
7/23 • Number of events 10 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
13.0%
3/23 • Number of events 4 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
66.7%
2/3 • Number of events 2 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
11.1%
3/27 • Number of events 4 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
21.7%
5/23 • Number of events 6 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
20.0%
1/5 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
7.4%
2/27 • Number of events 2 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Metabolism and nutrition disorders
Malnutrition
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.1%
3/27 • Number of events 3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
13.0%
3/23 • Number of events 3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
13.0%
3/23 • Number of events 3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.1%
3/27 • Number of events 5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
8.7%
2/23 • Number of events 2 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
20.0%
1/5 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Musculoskeletal and connective tissue disorders
Soft tissue swelling
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infected neoplasm
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour necrosis
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Nervous system disorders
Dizziness
|
7.4%
2/27 • Number of events 2 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Nervous system disorders
Headache
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
8.7%
2/23 • Number of events 2 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Nervous system disorders
Sciatica
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Psychiatric disorders
Dyssomnia
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Psychiatric disorders
Insomnia
|
7.4%
2/27 • Number of events 3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Renal and urinary disorders
Albuminuria
|
7.4%
2/27 • Number of events 4 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
13.0%
3/23 • Number of events 7 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Renal and urinary disorders
Glomerulonephritis
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
8.7%
2/23 • Number of events 3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Renal and urinary disorders
Hyperuricosuria
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Renal and urinary disorders
IgA nephropathy
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Renal and urinary disorders
Ischaemic nephropathy
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Renal and urinary disorders
Proteinuria
|
25.9%
7/27 • Number of events 12 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
26.1%
6/23 • Number of events 8 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
100.0%
5/5 • Number of events 8 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
33.3%
1/3 • Number of events 2 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Reproductive system and breast disorders
Scrotal ulcer
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial ulceration
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
3/27 • Number of events 3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
8.7%
2/23 • Number of events 3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
20.0%
1/5 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
8.7%
2/23 • Number of events 2 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
8.7%
2/23 • Number of events 5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
20.0%
1/5 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
11.1%
3/27 • Number of events 6 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
11.1%
3/27 • Number of events 3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.4%
2/27 • Number of events 2 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
3.7%
1/27 • Number of events 2 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Skin and subcutaneous tissue disorders
Immune-mediated dermatitis
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
25.9%
7/27 • Number of events 9 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
39.1%
9/23 • Number of events 12 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
60.0%
3/5 • Number of events 5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.4%
2/27 • Number of events 2 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
13.0%
3/23 • Number of events 3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.7%
1/27 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Vascular disorders
Hypertension
|
59.3%
16/27 • Number of events 23 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
65.2%
15/23 • Number of events 18 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
80.0%
4/5 • Number of events 5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
33.3%
1/3 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
|
Vascular disorders
Hypotension
|
0.00%
0/27 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
4.3%
1/23 • Number of events 1 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/5 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
0.00%
0/3 • All-cause mortality data were collected from randomization through the end of the study (up to 34 months). Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) were collected from the date of first study drug administration through 30 days after the last dose (up to 32.5 months).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information \& may request a further delay to protect its IP rights.
- Publication restrictions are in place
Restriction type: OTHER