Trial Outcomes & Findings for BMS-986156, Ipilimumab, and Nivolumab With or Without Stereotactic Body Radiation Therapy in Treating Patients With Advanced or Metastatic Lung/Chest or Liver Cancers (NCT NCT04021043)
NCT ID: NCT04021043
Last Updated: 2025-12-03
Results Overview
Evaluate dose of BMS-986156 (30 mg vs 100 mg) and dose limiting toxicities (DLTs) when combined with ipilimumab (3 mg/kg), and evaluate DLTs when BMS-986156 administered in combination with ipilimumab (3 mg/kg) or nivolumab (480 mg) with SABR
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
51 participants
Primary outcome timeframe
Median duration of follow-up 32.3 months (95% CI 8.6 to 56.0)
Results posted on
2025-12-03
Participant Flow
Dates of recruitment period: 08/2019 to 12/2021; Location: Single center trial that recruited patients at one hospital site (MD Anderson Cancer Center, Houston, TX)
Three patients on theIpilimumab + BMS-986156 (30 mg/kg) arm, one patient on Ipilimumab + BMS-986156 (100 mg/kg) arm and one patient on the Ipilimumab + BMS-986156 with SBRT arm discontinued BMS-986156 with Ipilimumab due to treatment-related adverse events.
Participant milestones
| Measure |
Ipilimumab + BMS-986156 (100 mg/kg) Arm
Group 1: Administered four cycles of Ipilimumab (3 mg/kg) + BMS-986156 (100 mg as dose level 2) every 3 weeks.
|
Ipilimumab + BMS-986156 With SBRT Arm
Group 2: Administered four cycles of Ipilimumab (3 mg/kg) + BMS-986156 (100 mg) every 3 weeks with SABR (50 Gy/4 fx or 60-70 Gy/10 fx to liver/lung lesions).
|
Nivolumab + BMS-986156 With SBRT Arm
Group 3: Administered four cycles of nivolumab (480 mg) + BMS-986156 (30 mg), every 4 weeks with SABR. Maintenance nivolumab given up to 2 years.
|
Ipilimumab + BMS-986156 (30 mg/kg) Arm
Group 1: Administered four cycles of Ipilimumab (3 mg/kg) + BMS-986156 (30 mg as dose level 1) every 3 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
20
|
10
|
|
Overall Study
COMPLETED
|
0
|
0
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
10
|
10
|
19
|
10
|
Reasons for withdrawal
| Measure |
Ipilimumab + BMS-986156 (100 mg/kg) Arm
Group 1: Administered four cycles of Ipilimumab (3 mg/kg) + BMS-986156 (100 mg as dose level 2) every 3 weeks.
|
Ipilimumab + BMS-986156 With SBRT Arm
Group 2: Administered four cycles of Ipilimumab (3 mg/kg) + BMS-986156 (100 mg) every 3 weeks with SABR (50 Gy/4 fx or 60-70 Gy/10 fx to liver/lung lesions).
|
Nivolumab + BMS-986156 With SBRT Arm
Group 3: Administered four cycles of nivolumab (480 mg) + BMS-986156 (30 mg), every 4 weeks with SABR. Maintenance nivolumab given up to 2 years.
|
Ipilimumab + BMS-986156 (30 mg/kg) Arm
Group 1: Administered four cycles of Ipilimumab (3 mg/kg) + BMS-986156 (30 mg as dose level 1) every 3 weeks.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
0
|
3
|
|
Overall Study
Death
|
3
|
1
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
6
|
1
|
|
Overall Study
Discontinued due to disease progression
|
5
|
7
|
10
|
4
|
Baseline Characteristics
BMS-986156, Ipilimumab, and Nivolumab With or Without Stereotactic Body Radiation Therapy in Treating Patients With Advanced or Metastatic Lung/Chest or Liver Cancers
Baseline characteristics by cohort
| Measure |
Ipilimumab + BMS-986156 With SBRT Arm
n=10 Participants
Group 2: Administered four cycles of Ipilimumab (3 mg/kg) + BMS-986156 (100 mg) every 3 weeks with SABR (50 Gy/4 fx or 60-70 Gy/10 fx to liver/lung lesions).
|
Nivolumab + BMS-986156 With SBRT Arm
n=20 Participants
Group 3: Administered four cycles of nivolumab (480 mg) + BMS-986156 (30 mg), every 4 weeks with SABR. Maintenance nivolumab given up to 2 years.
|
Total
n=50 Participants
Total of all reporting groups
|
Ipilimumab + BMS-986156 Arm (30 mg/kg)
n=10 Participants
Group 1: Administered four cycles of Ipilimumab (3 mg/kg) + BMS-986156 (30 mg as dose level 1) every 3 weeks.
|
Ipilimumab + BMS-986156 Arm (100 mg/kg)
n=10 Participants
Group 1: Administered four cycles of Ipilimumab (3 mg/kg) + BMS-986156 (100 mg as dose level 2) every 3 weeks.
|
|---|---|---|---|---|---|
|
Age, Continuous
|
65 years
n=6 Participants
|
60 years
n=24 Participants
|
61 years
n=15 Participants
|
59 years
n=3 Participants
|
61 years
n=3 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=6 Participants
|
5 Participants
n=24 Participants
|
20 Participants
n=15 Participants
|
6 Participants
n=3 Participants
|
5 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=6 Participants
|
15 Participants
n=24 Participants
|
30 Participants
n=15 Participants
|
4 Participants
n=3 Participants
|
5 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=6 Participants
|
1 Participants
n=24 Participants
|
3 Participants
n=15 Participants
|
2 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=6 Participants
|
19 Participants
n=24 Participants
|
47 Participants
n=15 Participants
|
8 Participants
n=3 Participants
|
10 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=6 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=6 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=6 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=6 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=6 Participants
|
1 Participants
n=24 Participants
|
3 Participants
n=15 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=6 Participants
|
18 Participants
n=24 Participants
|
44 Participants
n=15 Participants
|
7 Participants
n=3 Participants
|
10 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=6 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=6 Participants
|
1 Participants
n=24 Participants
|
3 Participants
n=15 Participants
|
2 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=6 Participants
|
20 participants
n=24 Participants
|
50 participants
n=15 Participants
|
10 participants
n=3 Participants
|
10 participants
n=3 Participants
|
PRIMARY outcome
Timeframe: Median duration of follow-up 32.3 months (95% CI 8.6 to 56.0)Evaluate dose of BMS-986156 (30 mg vs 100 mg) and dose limiting toxicities (DLTs) when combined with ipilimumab (3 mg/kg), and evaluate DLTs when BMS-986156 administered in combination with ipilimumab (3 mg/kg) or nivolumab (480 mg) with SABR
Outcome measures
| Measure |
Ipilimumab + BMS-986156 Arm (100 mg/kg)
n=10 Participants
Group 1: Administered four cycles of Ipilimumab (3 mg/kg) + BMS-986156 (100 mg as dose level 2) every 3 weeks.
|
Ipilimumab + BMS-986156 With SBRT Arm
n=10 Participants
Group 2: Administered four cycles of Ipilimumab (3 mg/kg) + BMS-986156 (100 mg) every 3 weeks with SABR (50 Gy/4 fx or 60-70 Gy/10 fx to liver/lung lesions).
|
Nivolumab + BMS-986156 With SBRT Arm
n=20 Participants
Group 3: Administered four cycles of nivolumab (480 mg) + BMS-986156 (30 mg), every 4 weeks with SABR. Maintenance nivolumab given up to 2 years.
|
Ipilimumab + BMS-986156 Arm (30 mg/kg)
n=10 Participants
Group 1: Administered four cycles of Ipilimumab (3 mg/kg) + BMS-986156 (30 mg as dose level 1) every 3 weeks.
|
|---|---|---|---|---|
|
Number of Dose Limiting Toxicities (DLTs)
|
1 Dose limiting toxicities
|
0 Dose limiting toxicities
|
0 Dose limiting toxicities
|
1 Dose limiting toxicities
|
SECONDARY outcome
Timeframe: Median duration of follow-up 32.3 months (95% CI 8.6 to 56.0)Population: Patients in the Ipilimumab + BMS-986156 Arm were not treated with SBRT and were not assessed for this Outcome Measure
Explore antitumor activity with SBRT and palliative radiation.
Outcome measures
| Measure |
Ipilimumab + BMS-986156 Arm (100 mg/kg)
Group 1: Administered four cycles of Ipilimumab (3 mg/kg) + BMS-986156 (100 mg as dose level 2) every 3 weeks.
|
Ipilimumab + BMS-986156 With SBRT Arm
n=10 Participants
Group 2: Administered four cycles of Ipilimumab (3 mg/kg) + BMS-986156 (100 mg) every 3 weeks with SABR (50 Gy/4 fx or 60-70 Gy/10 fx to liver/lung lesions).
|
Nivolumab + BMS-986156 With SBRT Arm
n=20 Participants
Group 3: Administered four cycles of nivolumab (480 mg) + BMS-986156 (30 mg), every 4 weeks with SABR. Maintenance nivolumab given up to 2 years.
|
Ipilimumab + BMS-986156 Arm (30 mg/kg)
Group 1: Administered four cycles of Ipilimumab (3 mg/kg) + BMS-986156 (30 mg as dose level 1) every 3 weeks.
|
|---|---|---|---|---|
|
Assess SBRT and Palliative Radiation Completion
Completion of SBRT without interruption due to RT-related AEs
|
—
|
10 Count of participants
|
20 Count of participants
|
—
|
|
Assess SBRT and Palliative Radiation Completion
Re-induction of SBRT due to progression per protocol
|
—
|
0 Count of participants
|
4 Count of participants
|
—
|
|
Assess SBRT and Palliative Radiation Completion
Received palliative RT while receiving immunotherapy
|
—
|
0 Count of participants
|
3 Count of participants
|
—
|
|
Assess SBRT and Palliative Radiation Completion
Received palliative RT after finishing all protocol-specified therapy
|
—
|
2 Count of participants
|
5 Count of participants
|
—
|
SECONDARY outcome
Timeframe: Median duration of follow-up 32.3 months (95% CI 8.6 to 56.0)Number of immune related responses of different immunotherapy schemes with or without SABR; Assessing complete response (CR), partial response (PR), and stable disease (SD)
Outcome measures
| Measure |
Ipilimumab + BMS-986156 Arm (100 mg/kg)
n=10 Participants
Group 1: Administered four cycles of Ipilimumab (3 mg/kg) + BMS-986156 (100 mg as dose level 2) every 3 weeks.
|
Ipilimumab + BMS-986156 With SBRT Arm
n=10 Participants
Group 2: Administered four cycles of Ipilimumab (3 mg/kg) + BMS-986156 (100 mg) every 3 weeks with SABR (50 Gy/4 fx or 60-70 Gy/10 fx to liver/lung lesions).
|
Nivolumab + BMS-986156 With SBRT Arm
n=20 Participants
Group 3: Administered four cycles of nivolumab (480 mg) + BMS-986156 (30 mg), every 4 weeks with SABR. Maintenance nivolumab given up to 2 years.
|
Ipilimumab + BMS-986156 Arm (30 mg/kg)
n=10 Participants
Group 1: Administered four cycles of Ipilimumab (3 mg/kg) + BMS-986156 (30 mg as dose level 1) every 3 weeks.
|
|---|---|---|---|---|
|
Immune-related Tumor Response
Immune Related Stable Disease (irSD)
|
1 Count of participants
|
4 Count of participants
|
7 Count of participants
|
2 Count of participants
|
|
Immune-related Tumor Response
Immune Related Partial Response (irPR)
|
0 Count of participants
|
0 Count of participants
|
2 Count of participants
|
1 Count of participants
|
|
Immune-related Tumor Response
Immune Related Progressive Disease (irPD)
|
5 Count of participants
|
5 Count of participants
|
14 Count of participants
|
1 Count of participants
|
SECONDARY outcome
Timeframe: Median duration of follow-up 32.3 months (95% CI 8.6 to 56.0)Population: Patients in the Ipilimumab + BMS-986156 Arms were not treated with SBRT and were not assessed for this Outcome Measure
Patient's change of tumor since intiation of treatment and patient's exhibiting out of field disease control.
Outcome measures
| Measure |
Ipilimumab + BMS-986156 Arm (100 mg/kg)
Group 1: Administered four cycles of Ipilimumab (3 mg/kg) + BMS-986156 (100 mg as dose level 2) every 3 weeks.
|
Ipilimumab + BMS-986156 With SBRT Arm
n=10 Participants
Group 2: Administered four cycles of Ipilimumab (3 mg/kg) + BMS-986156 (100 mg) every 3 weeks with SABR (50 Gy/4 fx or 60-70 Gy/10 fx to liver/lung lesions).
|
Nivolumab + BMS-986156 With SBRT Arm
n=20 Participants
Group 3: Administered four cycles of nivolumab (480 mg) + BMS-986156 (30 mg), every 4 weeks with SABR. Maintenance nivolumab given up to 2 years.
|
Ipilimumab + BMS-986156 Arm (30 mg/kg)
Group 1: Administered four cycles of Ipilimumab (3 mg/kg) + BMS-986156 (30 mg as dose level 1) every 3 weeks.
|
|---|---|---|---|---|
|
Out-of-field (Abscopal) Disease Control Rate (ACR)
Abscopal control rate
|
—
|
7 Count of participants
|
9 Count of participants
|
—
|
|
Out-of-field (Abscopal) Disease Control Rate (ACR)
Disease control rate
|
—
|
1 Count of participants
|
7 Count of participants
|
—
|
SECONDARY outcome
Timeframe: Median duration of follow-up 32.3 months (95% CI 8.6 to 56.0)Assesses partial response (PR) rate and complete response (CR) rate
Outcome measures
| Measure |
Ipilimumab + BMS-986156 Arm (100 mg/kg)
n=10 Participants
Group 1: Administered four cycles of Ipilimumab (3 mg/kg) + BMS-986156 (100 mg as dose level 2) every 3 weeks.
|
Ipilimumab + BMS-986156 With SBRT Arm
n=10 Participants
Group 2: Administered four cycles of Ipilimumab (3 mg/kg) + BMS-986156 (100 mg) every 3 weeks with SABR (50 Gy/4 fx or 60-70 Gy/10 fx to liver/lung lesions).
|
Nivolumab + BMS-986156 With SBRT Arm
n=20 Participants
Group 3: Administered four cycles of nivolumab (480 mg) + BMS-986156 (30 mg), every 4 weeks with SABR. Maintenance nivolumab given up to 2 years.
|
Ipilimumab + BMS-986156 Arm (30 mg/kg)
n=10 Participants
Group 1: Administered four cycles of Ipilimumab (3 mg/kg) + BMS-986156 (30 mg as dose level 1) every 3 weeks.
|
|---|---|---|---|---|
|
Out-of-field (Abscopal) Response Rate (ARR)
Objective Response Rate (ORR)
|
0 Count of participants
|
0 Count of participants
|
2 Count of participants
|
1 Count of participants
|
|
Out-of-field (Abscopal) Response Rate (ARR)
Abscopal response rate (ARR)
|
NA Count of participants
Patients not treated with SBRT on this arm
|
0 Count of participants
|
2 Count of participants
|
NA Count of participants
Patients not treated with SBRT on this arm
|
SECONDARY outcome
Timeframe: Median duration of follow-up 32.3 months (95% CI 8.6 to 56.0)Assessing complete response (CR), partial response (PR), and stable disease (SD)
Outcome measures
| Measure |
Ipilimumab + BMS-986156 Arm (100 mg/kg)
n=10 Participants
Group 1: Administered four cycles of Ipilimumab (3 mg/kg) + BMS-986156 (100 mg as dose level 2) every 3 weeks.
|
Ipilimumab + BMS-986156 With SBRT Arm
n=10 Participants
Group 2: Administered four cycles of Ipilimumab (3 mg/kg) + BMS-986156 (100 mg) every 3 weeks with SABR (50 Gy/4 fx or 60-70 Gy/10 fx to liver/lung lesions).
|
Nivolumab + BMS-986156 With SBRT Arm
n=20 Participants
Group 3: Administered four cycles of nivolumab (480 mg) + BMS-986156 (30 mg), every 4 weeks with SABR. Maintenance nivolumab given up to 2 years.
|
Ipilimumab + BMS-986156 Arm (30 mg/kg)
n=10 Participants
Group 1: Administered four cycles of Ipilimumab (3 mg/kg) + BMS-986156 (30 mg as dose level 1) every 3 weeks.
|
|---|---|---|---|---|
|
Tumor Burden: Disease Control Rate
|
3 Count of participants
|
4 Count of participants
|
11 Count of participants
|
3 Count of participants
|
Adverse Events
Ipilimumab + BMS-986156 Arm (30 mg/kg)
Serious events: 6 serious events
Other events: 10 other events
Deaths: 2 deaths
Ipilimumab + BMS-986156 Arm (100 mg/kg)
Serious events: 10 serious events
Other events: 10 other events
Deaths: 3 deaths
Ipilimumab + BMS-986156 With SBRT Arm
Serious events: 5 serious events
Other events: 10 other events
Deaths: 1 deaths
Nivolumab + BMS-986156 With SBRT Arm
Serious events: 9 serious events
Other events: 20 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Ipilimumab + BMS-986156 Arm (30 mg/kg)
n=10 participants at risk
Group 1: Administered four cycles of Ipilimumab (3 mg/kg) + BMS-986156 (30 mg as dose level 1) every 3 weeks.
|
Ipilimumab + BMS-986156 Arm (100 mg/kg)
n=10 participants at risk
Group 1: Administered four cycles of Ipilimumab (3 mg/kg) + BMS-986156 (100 mg as dose level 2) every 3 weeks.
|
Ipilimumab + BMS-986156 With SBRT Arm
n=10 participants at risk
Group 2: Administered four cycles of Ipilimumab (3 mg/kg) + BMS-986156 (100 mg) every 3 weeks with SABR (50 Gy/4 fx or 60-70 Gy/10 fx to liver/lung lesions).
|
Nivolumab + BMS-986156 With SBRT Arm
n=20 participants at risk
Group 3: Administered four cycles of nivolumab (480 mg) + BMS-986156 (30 mg), every 4 weeks with SABR. Maintenance nivolumab given up to 2 years.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Colitis
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
20.0%
2/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
2/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
20.0%
2/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
2/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
20.0%
2/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Gastrointestinal disorders
Hepatobiliary disorders - Other, specify
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
20.0%
2/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
2/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Vascular disorders
Thromboembolic event
|
20.0%
2/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
General disorders
Fatigue
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Hypercalcemia
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Gastrointestinal disorders
Nausea
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Pelvic pain
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Nervous system disorders
Delirium
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Infections and infestations
Lung infection
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Gastrointestinal disorders
Alanine aminotransferase increased
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
5.0%
1/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Infections and infestations
Anorectal infection
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Gastrointestinal disorders
Aspartate aminotransferase increased
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
5.0%
1/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
5.0%
1/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
5.0%
1/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
General disorders
Dehydration
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
General disorders
Dysphagia
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
5.0%
1/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Blood and lymphatic system disorders
Gastric hemorrhage
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
General disorders
Headache
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
5.0%
1/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
General disorders
Hypoxia
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
5.0%
1/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
General disorders
Penile pain
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
5.0%
1/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
5.0%
1/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
5.0%
1/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
General disorders
Spermatic cord obstruction
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Infections and infestations
Urinary tract infection
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Nervous system disorders
Vasovagal reaction
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Blood and lymphatic system disorders
Blood bilirubin increased
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
5.0%
1/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
General disorders
Death NOS
|
50.0%
5/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
30.0%
3/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
15.0%
3/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
General disorders
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify *
|
30.0%
3/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
20.0%
2/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
5.0%
1/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Nervous system disorders
Encephalopathy
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
Other adverse events
| Measure |
Ipilimumab + BMS-986156 Arm (30 mg/kg)
n=10 participants at risk
Group 1: Administered four cycles of Ipilimumab (3 mg/kg) + BMS-986156 (30 mg as dose level 1) every 3 weeks.
|
Ipilimumab + BMS-986156 Arm (100 mg/kg)
n=10 participants at risk
Group 1: Administered four cycles of Ipilimumab (3 mg/kg) + BMS-986156 (100 mg as dose level 2) every 3 weeks.
|
Ipilimumab + BMS-986156 With SBRT Arm
n=10 participants at risk
Group 2: Administered four cycles of Ipilimumab (3 mg/kg) + BMS-986156 (100 mg) every 3 weeks with SABR (50 Gy/4 fx or 60-70 Gy/10 fx to liver/lung lesions).
|
Nivolumab + BMS-986156 With SBRT Arm
n=20 participants at risk
Group 3: Administered four cycles of nivolumab (480 mg) + BMS-986156 (30 mg), every 4 weeks with SABR. Maintenance nivolumab given up to 2 years.
|
|---|---|---|---|---|
|
Renal and urinary disorders
Hyperuricemia
|
20.0%
2/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infection
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Vascular disorders
Portal vein thrombosis
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
General disorders
Spermatic cord obstruction
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Nervous system disorders
Vasovagal reaction
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Nervous system disorders
Delirium
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
General disorders
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify*
|
30.0%
3/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
20.0%
2/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
5.0%
1/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Blood and lymphatic system disorders
Encephalopathy
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
General disorders
Anxiety
|
20.0%
2/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
General disorders
Blurred vision
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
20.0%
2/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
General disorders
Dry mouth
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Nervous system disorders
Gait disturbance
|
20.0%
2/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Investigations
Investigations - Other, specify
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
5.0%
1/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Nervous system disorders
Social circumstances - Other, specify
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
5.0%
1/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Nervous system disorders
Toothache
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Renal and urinary disorders
Urinary retention
|
20.0%
2/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Renal and urinary disorders
Urinary tract pain
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
5.0%
1/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
General disorders
Vaginal pain
|
20.0%
2/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Metabolism and nutrition disorders
Weight gain
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
20.0%
2/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
2/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
General disorders
Adrenal insufficiency
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Nervous system disorders
Hyperhidrosis
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Nervous system disorders
Memory impairment
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
General disorders
Uveitis
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
60.0%
6/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
40.0%
4/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
20.0%
4/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Blood and lymphatic system disorders
Edema limbs
|
50.0%
5/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
50.0%
5/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
25.0%
5/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
60.0%
6/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
40.0%
4/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
20.0%
4/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
5/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
20.0%
2/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
30.0%
3/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
15.0%
3/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
General disorders
Chest wall pain
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
20.0%
2/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
70.0%
7/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
35.0%
7/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Renal and urinary disorders
Creatinine increased
|
40.0%
4/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
20.0%
2/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
30.0%
3/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
15.0%
3/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
20.0%
2/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
40.0%
4/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
30.0%
3/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
15.0%
3/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Metabolism and nutrition disorders
Weight loss
|
50.0%
5/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
30.0%
3/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
15.0%
3/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Blood and lymphatic system disorders
Anemia
|
40.0%
4/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
20.0%
2/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
40.0%
4/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
20.0%
4/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
General disorders
Fever
|
40.0%
4/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
40.0%
4/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
20.0%
4/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
50.0%
5/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
30.0%
3/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
General disorders
Pain
|
30.0%
3/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
40.0%
4/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
20.0%
4/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Gastrointestinal disorders
Alanine aminotransferase increased
|
50.0%
5/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
30.0%
3/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
20.0%
2/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
2/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
General disorders
Hypokalemia
|
30.0%
3/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
30.0%
3/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
5.0%
1/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Gastrointestinal disorders
Constipation
|
40.0%
4/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
20.0%
2/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
2/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
General disorders
Dizziness
|
20.0%
2/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
30.0%
3/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
5.0%
1/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
General disorders
Hypercalcemia
|
40.0%
4/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
20.0%
2/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
2/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
20.0%
2/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
30.0%
3/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
15.0%
3/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
General disorders
Insomnia
|
40.0%
4/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
5.0%
1/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
General disorders
Hypothyroidism
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
40.0%
4/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
20.0%
4/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
30.0%
3/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
5.0%
1/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Gastrointestinal disorders
Colitis
|
30.0%
3/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
20.0%
2/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
40.0%
4/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
20.0%
4/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
General disorders
Headache
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
30.0%
3/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
15.0%
3/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
50.0%
5/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
25.0%
5/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
30.0%
3/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
5.0%
1/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
40.0%
4/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Gastrointestinal disorders
Mucositis oral
|
20.0%
2/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
20.0%
2/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
2/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
20.0%
2/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
2/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Renal and urinary disorders
Urinary frequency
|
30.0%
3/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
5.0%
1/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Gastrointestinal disorders
Vomiting
|
30.0%
3/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
5.0%
1/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Blood and lymphatic system disorders
White blood cell decreased
|
20.0%
2/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
5.0%
1/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Infections and infestations
Urinary tract infection
|
50.0%
5/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Gastrointestinal disorders
Abdominal distension
|
20.0%
2/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
5.0%
1/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
30.0%
3/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
5.0%
1/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
20.0%
2/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
2/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Blood and lymphatic system disorders
Blood bilirubin increased
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
20.0%
2/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
2/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
20.0%
2/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
5.0%
1/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
20.0%
2/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
General disorders
Hyponatremia
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
20.0%
2/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
20.0%
2/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
2/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Gastrointestinal disorders
Hepatobiliary disorders - Other, specify
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
20.0%
2/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
2/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
20.0%
2/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
5.0%
1/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Cardiac disorders
Hypoxia
|
30.0%
3/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
20.0%
2/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
General disorders
Allergic reaction
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
5.0%
1/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
5.0%
1/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Blood and lymphatic system disorders
Dehydration
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
20.0%
2/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Blood and lymphatic system disorders
Thromboembolic event
|
30.0%
3/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Gastrointestinal disorders
Diarrhea
|
60.0%
6/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
30.0%
3/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
30.0%
3/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
15.0%
3/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Gastrointestinal disorders
Aspartate aminotransferase increased
|
40.0%
4/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
50.0%
5/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
30.0%
3/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
15.0%
3/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
70.0%
7/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
20.0%
2/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
100.0%
10/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
50.0%
10/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
General disorders
Fatigue
|
70.0%
7/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
20.0%
2/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
70.0%
7/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
35.0%
7/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
General disorders
Abdominal pain
|
60.0%
6/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
20.0%
2/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
70.0%
7/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
35.0%
7/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
General disorders
Anorexia
|
50.0%
5/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
30.0%
3/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
60.0%
6/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
30.0%
6/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
General disorders
Back pain
|
50.0%
5/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
90.0%
9/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
45.0%
9/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Rash
|
80.0%
8/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
40.0%
4/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
20.0%
4/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Infections and infestations
Anorectal infection
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Cardiac disorders
Cardiac disorders - Cardiac troponin T increased
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Blood and lymphatic system disorders
Gastric hemorrhage
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Vascular disorders
Hypotension
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
5.0%
1/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
General disorders
Penile pain
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
5.0%
1/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
20.0%
2/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
5.0%
1/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
5.0%
1/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
5.0%
1/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Renal and urinary disorders
Pelvic pain
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
1/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
5.0%
1/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
0.00%
0/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
20.0%
2/10 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
10.0%
2/20 • Baseline to at least 100 days after the last dose of study treatment, up to 5 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place