Trial Outcomes & Findings for A Study of Sotorasib (AMG 510) in Participants With Stage IV NSCLC Whose Tumors Harbor a KRAS p.G12C Mutation in Need of First-line Treatment (NCT NCT04933695)
NCT ID: NCT04933695
Last Updated: 2026-07-13
Results Overview
Objective response was defined as best overall response (BOR) of complete response (CR) or partial response (PR), as defined by RECIST 1.1. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis \<10 mm. PR was defined as at least a 30% decrease in the sum of diameter (SOD) of target lesions, taking as reference the baseline sum diameters. Progressive disease (PD) was defined as at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. Responses were assessed based on BICR.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
42 participants
Primary outcome timeframe
From the first dose of trial drug until min (last dose + 30 days, end of trial [EOT]); median [min, max] duration was 5.32 [0.8, 30.9] months
Results posted on
2026-07-13
Participant Flow
A total of 42 participants were enrolled across 17 trial centers in the United States and Europe from January 2022 to May 2025.
Participants received sotorasib at either 960 mg and 240 mg orally, once daily (QD). This trial was discontinued for strategic reasons.
Participant milestones
| Measure |
Sotorasib 240 mg
Participants with metastatic non-small cell lung cancer (NSCLC) with Kirsten rat sarcoma (KRAS) p.G12C mutation whose tumors express \<1% programmed death-ligand 1 (PD-L1) and/or serine/threonine kinase 11 (STK11) mutation in need of first line treatment received treatment with sotorasib at 240 mg orally, QD, in each 21-days treatment cycle or until disease progression or unacceptable toxicity, whichever occurred first.
|
Sotorasib 960 mg
Participants with metastatic NSCLC with KRAS p.G12C mutation whose tumors express \<1% PD-L1 and/or STK11 mutation in need of first line treatment received treatment with sotorasib at 960 mg orally, QD, in each 21-days treatment cycle or until disease progression or unacceptable toxicity, whichever occurred first.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
21
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
21
|
21
|
Reasons for withdrawal
| Measure |
Sotorasib 240 mg
Participants with metastatic non-small cell lung cancer (NSCLC) with Kirsten rat sarcoma (KRAS) p.G12C mutation whose tumors express \<1% programmed death-ligand 1 (PD-L1) and/or serine/threonine kinase 11 (STK11) mutation in need of first line treatment received treatment with sotorasib at 240 mg orally, QD, in each 21-days treatment cycle or until disease progression or unacceptable toxicity, whichever occurred first.
|
Sotorasib 960 mg
Participants with metastatic NSCLC with KRAS p.G12C mutation whose tumors express \<1% PD-L1 and/or STK11 mutation in need of first line treatment received treatment with sotorasib at 960 mg orally, QD, in each 21-days treatment cycle or until disease progression or unacceptable toxicity, whichever occurred first.
|
|---|---|---|
|
Overall Study
Withdrawal of consent from trial
|
4
|
0
|
|
Overall Study
Decision by Sponsor
|
2
|
5
|
|
Overall Study
Death
|
15
|
16
|
Baseline Characteristics
A Study of Sotorasib (AMG 510) in Participants With Stage IV NSCLC Whose Tumors Harbor a KRAS p.G12C Mutation in Need of First-line Treatment
Baseline characteristics by cohort
| Measure |
Sotorasib
n=42 Participants
Participants with metastatic NSCLC with KRAS p.G12C mutation whose tumors express \<1% PD-L1 and/or STK11 mutation in need of first line treatment received treatment with sotorasib at 960 mg or 240 mg orally, QD, in each 21-days treatment cycle or until disease progression or unacceptable toxicity, whichever occurred first.
|
|---|---|
|
Age, Continuous
|
66.5 years
STANDARD_DEVIATION 9.8 • n=20 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
White
|
41 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
42 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: From the first dose of trial drug until min (last dose + 30 days, end of trial [EOT]); median [min, max] duration was 5.32 [0.8, 30.9] monthsPopulation: The full analysis set (FAS) was defined as all participants who received at least 1 dose of sotorasib and have one or more measurable lesions at baseline as assessed by BICR using RECIST 1.1. As per-planned analysis, the data for this outcome measure were collected, analyzed and reported as a single cohort.
Objective response was defined as best overall response (BOR) of complete response (CR) or partial response (PR), as defined by RECIST 1.1. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis \<10 mm. PR was defined as at least a 30% decrease in the sum of diameter (SOD) of target lesions, taking as reference the baseline sum diameters. Progressive disease (PD) was defined as at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. Responses were assessed based on BICR.
Outcome measures
| Measure |
Sotorasib
n=41 Participants
Participants with metastatic NSCLC with KRAS p.G12C mutation whose tumors express \<1% PD-L1 and/or STK11 mutation in need of first line treatment received treatment with sotorasib at 960 mg or 240 mg orally, QD, in each 21-days treatment cycle or until disease progression or unacceptable toxicity, whichever occurred first.
|
Sotorasib 960 mg
Participants with metastatic NSCLC with KRAS p.G12C mutation whose tumors express \<1% PD-L1 and/or STK11 mutation in need of first line treatment received treatment with sotorasib at 960 mg orally, QD, in each 21-days treatment cycle or until disease progression or unacceptable toxicity, whichever occurred first.
|
|---|---|---|
|
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR)
|
26.8 percentage of participants
Interval 14.2 to 42.9
|
—
|
SECONDARY outcome
Timeframe: From randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] monthsPopulation: The FAS was defined as all participants who received at least 1 dose of sotorasib and have one or more measurable lesions at baseline as assessed by BICR using RECIST 1.1. As per-planned analysis, the data for this outcome measure were collected, analyzed and reported as a single cohort.
DCR was defined as the percentage of participants with an OR or stable disease (SD) per RECIST v1.1. CR: disappearance of all target lesions. All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to \<10 mm. PR: at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (this includes baseline sum if that is the smallest on study).
Outcome measures
| Measure |
Sotorasib
n=41 Participants
Participants with metastatic NSCLC with KRAS p.G12C mutation whose tumors express \<1% PD-L1 and/or STK11 mutation in need of first line treatment received treatment with sotorasib at 960 mg or 240 mg orally, QD, in each 21-days treatment cycle or until disease progression or unacceptable toxicity, whichever occurred first.
|
Sotorasib 960 mg
Participants with metastatic NSCLC with KRAS p.G12C mutation whose tumors express \<1% PD-L1 and/or STK11 mutation in need of first line treatment received treatment with sotorasib at 960 mg orally, QD, in each 21-days treatment cycle or until disease progression or unacceptable toxicity, whichever occurred first.
|
|---|---|---|
|
Disease Control Rate (DCR) Per RECIST Version 1.1 as Assessed by BICR
|
73.2 percentage of participants
Interval 57.1 to 85.8
|
—
|
SECONDARY outcome
Timeframe: From randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] monthsPopulation: The FAS was defined as all participants who received at least 1 dose of sotorasib and have one or more measurable lesions at baseline as assessed by BICR using RECIST 1.1. Only participants who had achieved OR were evaluated for DOR. As per-planned analysis, the data for this outcome measure were collected, analyzed and reported as a single cohort.
DOR was defined as time from the first documentation of OR subsequently confirmed until the first documentation of PD or death due to any cause, whichever comes first. CR: disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (target or non-target) must have a reduction in their short axis \<10 mm. PR: at least a 30% decrease in the SOD of target lesions, taking as reference the baseline sum diameters. PD: at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.
Outcome measures
| Measure |
Sotorasib
n=11 Participants
Participants with metastatic NSCLC with KRAS p.G12C mutation whose tumors express \<1% PD-L1 and/or STK11 mutation in need of first line treatment received treatment with sotorasib at 960 mg or 240 mg orally, QD, in each 21-days treatment cycle or until disease progression or unacceptable toxicity, whichever occurred first.
|
Sotorasib 960 mg
Participants with metastatic NSCLC with KRAS p.G12C mutation whose tumors express \<1% PD-L1 and/or STK11 mutation in need of first line treatment received treatment with sotorasib at 960 mg orally, QD, in each 21-days treatment cycle or until disease progression or unacceptable toxicity, whichever occurred first.
|
|---|---|---|
|
Duration of Response (DOR) Per RECIST Version 1.1 as Assessed by BICR
|
7.2 months
Interval 2.8 to
Upper confidence interval (CI) was not calculable due to insufficient event data occurring above the median.
|
—
|
SECONDARY outcome
Timeframe: From randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] monthsPopulation: The FAS was defined as all participants who received at least 1 dose of sotorasib and have one or more measurable lesions at baseline as assessed by BICR using RECIST 1.1. Only participants who had achieved OR were evaluated for TTR. As per-planned analysis, the data for this outcome measure were collected, analyzed and reported as a single cohort.
TTR was defined as time from first dose date to the first documentation of PR or CR subsequently confirmed. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis \<10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline sum diameters. PD was defined as at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.
Outcome measures
| Measure |
Sotorasib
n=11 Participants
Participants with metastatic NSCLC with KRAS p.G12C mutation whose tumors express \<1% PD-L1 and/or STK11 mutation in need of first line treatment received treatment with sotorasib at 960 mg or 240 mg orally, QD, in each 21-days treatment cycle or until disease progression or unacceptable toxicity, whichever occurred first.
|
Sotorasib 960 mg
Participants with metastatic NSCLC with KRAS p.G12C mutation whose tumors express \<1% PD-L1 and/or STK11 mutation in need of first line treatment received treatment with sotorasib at 960 mg orally, QD, in each 21-days treatment cycle or until disease progression or unacceptable toxicity, whichever occurred first.
|
|---|---|---|
|
Time to Response (TTR) Per RECIST Version 1.1 as Assessed by BICR
|
1.5 months
Interval 1.0 to 6.0
|
—
|
SECONDARY outcome
Timeframe: From randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] monthsPopulation: The FAS was defined as all participants who received at least 1 dose of sotorasib and have one or more measurable lesions at baseline as assessed by BICR using RECIST 1.1. As per-planned analysis, the data for this outcome measure were collected, analyzed and reported as a single cohort.
PFS by BICR was defined as the time from first dose date to disease progression or death due to any cause (whichever comes first). PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the baseline SOD of target lesions.
Outcome measures
| Measure |
Sotorasib
n=41 Participants
Participants with metastatic NSCLC with KRAS p.G12C mutation whose tumors express \<1% PD-L1 and/or STK11 mutation in need of first line treatment received treatment with sotorasib at 960 mg or 240 mg orally, QD, in each 21-days treatment cycle or until disease progression or unacceptable toxicity, whichever occurred first.
|
Sotorasib 960 mg
Participants with metastatic NSCLC with KRAS p.G12C mutation whose tumors express \<1% PD-L1 and/or STK11 mutation in need of first line treatment received treatment with sotorasib at 960 mg orally, QD, in each 21-days treatment cycle or until disease progression or unacceptable toxicity, whichever occurred first.
|
|---|---|---|
|
Progression-free Survival (PFS) as Assessed by BICR
|
4.5 months
Interval 2.7 to 8.3
|
—
|
SECONDARY outcome
Timeframe: From randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] monthsPopulation: Investigator FAS (iFAS) included all participants who received at least 1 dose of sotorasib. As per-planned analysis, the data for this outcome measure were collected, analyzed and reported as a single cohort.
OS was defined as the time from first dose date until event of death due to any cause.
Outcome measures
| Measure |
Sotorasib
n=42 Participants
Participants with metastatic NSCLC with KRAS p.G12C mutation whose tumors express \<1% PD-L1 and/or STK11 mutation in need of first line treatment received treatment with sotorasib at 960 mg or 240 mg orally, QD, in each 21-days treatment cycle or until disease progression or unacceptable toxicity, whichever occurred first.
|
Sotorasib 960 mg
Participants with metastatic NSCLC with KRAS p.G12C mutation whose tumors express \<1% PD-L1 and/or STK11 mutation in need of first line treatment received treatment with sotorasib at 960 mg orally, QD, in each 21-days treatment cycle or until disease progression or unacceptable toxicity, whichever occurred first.
|
|---|---|---|
|
Overall Survival (OS)
|
11.8 months
Interval 7.7 to 16.4
|
—
|
SECONDARY outcome
Timeframe: From the first dose of trial drug until min (last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] monthsPopulation: The safety analysis set (SAS) was defined as all participants who were enrolled and received at least 1 dose of sotorasib.
TEAEs are AEs starting on or after the first dose of sotorasib as determined by the flag indicating if the AE started prior to the first dose on the Events case report form (CRF) and up to and including 30 days after the last dose of sotorasib or the EOT date, whichever is earlier. A treatment-related TEAE is any TEAE with the relationship flag on the events CRF indicating there is a reasonable possibility that the event may have been caused by investigational medicinal product. Clinically significant changes in vital signs, electrocardiograms (ECGs), and clinical laboratory tests were included as TEAEs.
Outcome measures
| Measure |
Sotorasib
n=21 Participants
Participants with metastatic NSCLC with KRAS p.G12C mutation whose tumors express \<1% PD-L1 and/or STK11 mutation in need of first line treatment received treatment with sotorasib at 960 mg or 240 mg orally, QD, in each 21-days treatment cycle or until disease progression or unacceptable toxicity, whichever occurred first.
|
Sotorasib 960 mg
n=21 Participants
Participants with metastatic NSCLC with KRAS p.G12C mutation whose tumors express \<1% PD-L1 and/or STK11 mutation in need of first line treatment received treatment with sotorasib at 960 mg orally, QD, in each 21-days treatment cycle or until disease progression or unacceptable toxicity, whichever occurred first.
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-related TEAEs
TEAEs
|
19 count of participants
|
21 count of participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-related TEAEs
Treatment-related TEAEs
|
13 count of participants
|
11 count of participants
|
SECONDARY outcome
Timeframe: Cycles 1 and 2: Day 1 pre-dose and 1 hour post-dose; Cycles 3, 4 and, 5: Day 1 pre-dose (cycle length = 21 days)Population: The pharmacokinetic (PK) analysis set included all participants who have received at least 1 dose of sotorasib. Only participants with available data were included in this endpoint.
Blood samples were collected at specified timepoints.
Outcome measures
| Measure |
Sotorasib
n=17 Participants
Participants with metastatic NSCLC with KRAS p.G12C mutation whose tumors express \<1% PD-L1 and/or STK11 mutation in need of first line treatment received treatment with sotorasib at 960 mg or 240 mg orally, QD, in each 21-days treatment cycle or until disease progression or unacceptable toxicity, whichever occurred first.
|
Sotorasib 960 mg
n=21 Participants
Participants with metastatic NSCLC with KRAS p.G12C mutation whose tumors express \<1% PD-L1 and/or STK11 mutation in need of first line treatment received treatment with sotorasib at 960 mg orally, QD, in each 21-days treatment cycle or until disease progression or unacceptable toxicity, whichever occurred first.
|
|---|---|---|
|
Plasma Concentration of Sotorasib
Cycle 4 Day 1: pre-dose
|
366 ng/mL
Standard Deviation 590
|
255 ng/mL
Standard Deviation 277
|
|
Plasma Concentration of Sotorasib
Cycle 5 Day 1: pre-dose
|
211 ng/mL
Standard Deviation 353
|
164 ng/mL
Standard Deviation 153
|
|
Plasma Concentration of Sotorasib
Cycle 1 Day 1: 1 hour
|
6840 ng/mL
Standard Deviation 4060
|
11600 ng/mL
Standard Deviation 6880
|
|
Plasma Concentration of Sotorasib
Cycle 1 Day 1 pre-dose
|
0.00 ng/mL
Standard Deviation 0.00
|
0.00 ng/mL
Standard Deviation 0.00
|
|
Plasma Concentration of Sotorasib
Cycle 2 Day 1 pre-dose
|
394 ng/mL
Standard Deviation 858
|
883 ng/mL
Standard Deviation 2140
|
|
Plasma Concentration of Sotorasib
Cycle 2 Day 1: 1 hour
|
4870 ng/mL
Standard Deviation 3200
|
7340 ng/mL
Standard Deviation 3760
|
|
Plasma Concentration of Sotorasib
Cycle 3 Day 1: pre-dose
|
347 ng/mL
Standard Deviation 698
|
259 ng/mL
Standard Deviation 331
|
Adverse Events
Sotorasib 240 mg
Serious events: 9 serious events
Other events: 18 other events
Deaths: 15 deaths
Sotorasib 960 mg
Serious events: 9 serious events
Other events: 20 other events
Deaths: 16 deaths
Serious adverse events
| Measure |
Sotorasib 240 mg
n=21 participants at risk
Participants with metastatic NSCLC with KRAS p.G12C mutation whose tumors express \<1% PD-L1 and/or STK11 mutation in need of first line treatment received treatment with sotorasib at 240 mg orally, QD, in each 21-days treatment cycle or until disease progression or unacceptable toxicity, whichever occurred first.
|
Sotorasib 960 mg
n=21 participants at risk
Participants with metastatic NSCLC with KRAS p.G12C mutation whose tumors express \<1% PD-L1 and/or STK11 mutation in need of first line treatment received treatment with sotorasib at 960 mg orally, QD, in each 21-days treatment cycle or until disease progression or unacceptable toxicity, whichever occurred first.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Cardiac disorders
Acute cardiac event
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Cardiac disorders
Cardiac failure
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
General disorders
General physical health deterioration
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
9.5%
2/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
General disorders
Multiple organ dysfunction syndrome
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
General disorders
Oedema peripheral
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Infections and infestations
Pneumonia
|
9.5%
2/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Infections and infestations
Sepsis
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to skin
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Nervous system disorders
Cerebral ischaemia
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
9.5%
2/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
9.5%
2/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
9.5%
2/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Vascular disorders
Hypotension
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Vascular disorders
Thrombophlebitis migrans
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
Other adverse events
| Measure |
Sotorasib 240 mg
n=21 participants at risk
Participants with metastatic NSCLC with KRAS p.G12C mutation whose tumors express \<1% PD-L1 and/or STK11 mutation in need of first line treatment received treatment with sotorasib at 240 mg orally, QD, in each 21-days treatment cycle or until disease progression or unacceptable toxicity, whichever occurred first.
|
Sotorasib 960 mg
n=21 participants at risk
Participants with metastatic NSCLC with KRAS p.G12C mutation whose tumors express \<1% PD-L1 and/or STK11 mutation in need of first line treatment received treatment with sotorasib at 960 mg orally, QD, in each 21-days treatment cycle or until disease progression or unacceptable toxicity, whichever occurred first.
|
|---|---|---|
|
Cardiac disorders
Heart failure with midrange ejection fraction
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Blood and lymphatic system disorders
Anaemia
|
9.5%
2/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
14.3%
3/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Cardiac disorders
Tachycardia
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Congenital, familial and genetic disorders
Dysmorphism
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Endocrine disorders
Hyperthyroidism
|
9.5%
2/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Endocrine disorders
Hypothyroidism
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Gastrointestinal disorders
Abdominal distension
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Gastrointestinal disorders
Abdominal pain
|
9.5%
2/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
9.5%
2/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Gastrointestinal disorders
Constipation
|
14.3%
3/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
9.5%
2/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
7/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
33.3%
7/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
9.5%
2/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Gastrointestinal disorders
Dysphagia
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Gastrointestinal disorders
Flatulence
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Gastrointestinal disorders
Nausea
|
14.3%
3/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
23.8%
5/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Gastrointestinal disorders
Stomatitis
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Gastrointestinal disorders
Vomiting
|
19.0%
4/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
General disorders
Asthenia
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
14.3%
3/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
General disorders
Chest pain
|
9.5%
2/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
28.6%
6/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
General disorders
Fatigue
|
19.0%
4/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
9.5%
2/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
General disorders
Influenza like illness
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
General disorders
Mucosal inflammation
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
General disorders
Non-cardiac chest pain
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
General disorders
Oedema peripheral
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
9.5%
2/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
General disorders
Pain
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
General disorders
Pyrexia
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
9.5%
2/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Hepatobiliary disorders
Biliary dilatation
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Infections and infestations
Bronchopulmonary aspergillosis allergic
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Infections and infestations
COVID-19
|
9.5%
2/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
9.5%
2/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Infections and infestations
Cellulitis
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
9.5%
2/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Infections and infestations
Root canal infection
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Infections and infestations
Urinary tract infection
|
9.5%
2/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Investigations
Eastern Cooperative Oncology Group performance status worsened
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Investigations
Ejection fraction decreased
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Investigations
SARS-CoV-2 antibody test positive
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Investigations
Weight decreased
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
14.3%
3/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
9.5%
2/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Metabolism and nutrition disorders
Food aversion
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Metabolism and nutrition disorders
Hyperamylasaemia
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Metabolism and nutrition disorders
Hypercreatininaemia
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.5%
2/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
3/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
19.0%
4/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
9.5%
2/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.5%
2/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
9.5%
2/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Nervous system disorders
Dysgeusia
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Nervous system disorders
Headache
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
9.5%
2/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Nervous system disorders
Neuralgia
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Nervous system disorders
Neuropathy peripheral
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Psychiatric disorders
Anxiety
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
14.3%
3/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Psychiatric disorders
Insomnia
|
9.5%
2/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Renal and urinary disorders
Acute kidney injury
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Renal and urinary disorders
Pollakiuria
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Renal and urinary disorders
Proteinuria
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
14.3%
3/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
19.0%
4/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
9.5%
2/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
9.5%
2/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
19.0%
4/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
9.5%
2/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
9.5%
2/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Vascular disorders
Extremity necrosis
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Vascular disorders
Hypertension
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
|
Vascular disorders
Thrombosis
|
4.8%
1/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
0.00%
0/21 • For mortality reporting: from randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months. For AE reporting: from the first dose of trial drug until min(last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months.
Serious AEs and other AEs are reported from the first dose date of IP until 30 days after the last dose of trial drug, or the EOT date, whichever is earlier.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER