Trial Outcomes & Findings for A Study of BMS-986207 Given Alone and in Combination With Nivolumab or With Nivolumab and Ipilimumab in Advanced Solid Tumors (NCT NCT02913313)

NCT ID: NCT02913313

Last Updated: 2025-04-20

Results Overview

An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

101 participants

Primary outcome timeframe

From first dose (Day 1) untill 100 days after last dose (Up to approximately 27 months)

Results posted on

2025-04-20

Participant Flow

Participants were not randomized in Part 2B arm.

Participant milestones

Participant milestones
Measure
Part 1A BMS-986207 Safety Run In
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with total 48 mg of BMS-986207 as 60 minutes intravenous infusion in one cycle (each cycle of 8 weeks).
Part 1A BMS-986207 20 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 20 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 80 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 800 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 1600 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w) or 2 doses of BMS-986207 administered every 4 weeks (q4w).
Part 2A BMS-986207 800 mg (CRC)
Participants with colorectal cancer (CRC) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1B BMS-986207 80 mg + Nivolumab 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
Part 1B BMS-986207 240 mg + Nivolumab 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
Part 1B BMS-986207 1600 mg + Nivolumab 480 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Part 1B: BMS-986207 480 mg + Nivolumab 480 mg
Participants with CRC or ovarian cancer or hepatocellular carcinoma were administered with 480 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Part 1C BMS-986207 1200 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with Nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and Ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the Nivolumab infusion.
Part 1C BMS-986207 600 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Part 2C BMS-986207 600 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
Participants with first-line non-small cell lung cancer were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Overall Study
STARTED
1
2
3
4
8
4
20
4
4
4
18
6
18
5
Overall Study
COMPLETED
0
0
0
0
0
0
0
0
0
0
0
0
1
0
Overall Study
NOT COMPLETED
1
2
3
4
8
4
20
4
4
4
18
6
17
5

Reasons for withdrawal

Reasons for withdrawal
Measure
Part 1A BMS-986207 Safety Run In
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with total 48 mg of BMS-986207 as 60 minutes intravenous infusion in one cycle (each cycle of 8 weeks).
Part 1A BMS-986207 20 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 20 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 80 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 800 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 1600 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w) or 2 doses of BMS-986207 administered every 4 weeks (q4w).
Part 2A BMS-986207 800 mg (CRC)
Participants with colorectal cancer (CRC) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1B BMS-986207 80 mg + Nivolumab 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
Part 1B BMS-986207 240 mg + Nivolumab 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
Part 1B BMS-986207 1600 mg + Nivolumab 480 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Part 1B: BMS-986207 480 mg + Nivolumab 480 mg
Participants with CRC or ovarian cancer or hepatocellular carcinoma were administered with 480 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Part 1C BMS-986207 1200 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with Nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and Ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the Nivolumab infusion.
Part 1C BMS-986207 600 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Part 2C BMS-986207 600 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
Participants with first-line non-small cell lung cancer were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Overall Study
DISEASE PROGRESSION
1
2
2
4
6
4
19
3
4
4
11
5
14
3
Overall Study
Not Reported
0
0
0
0
1
0
0
0
0
0
4
0
0
0
Overall Study
Other reasons
0
0
0
0
1
0
0
0
0
0
1
0
0
0
Overall Study
Withdrawal by Subject
0
0
1
0
0
0
1
1
0
0
1
0
0
0
Overall Study
ADVERSE EVENT UNRELATED TO STUDY DRUG
0
0
0
0
0
0
0
0
0
0
1
0
1
1
Overall Study
STUDY DRUG TOXICITY
0
0
0
0
0
0
0
0
0
0
0
1
2
1

Baseline Characteristics

A Study of BMS-986207 Given Alone and in Combination With Nivolumab or With Nivolumab and Ipilimumab in Advanced Solid Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Part 1A BMS-986207 Safety Run In
n=1 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with total 48 mg of BMS-986207 as 60 minutes intravenous infusion in one cycle (each cycle of 8 weeks).
Part 1A BMS-986207 20 mg
n=2 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 20 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 80 mg
n=3 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 240 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 800 mg
n=8 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 1600 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w) or 2 doses of BMS-986207 administered every 4 weeks (q4w).
Part 2A BMS-986207 800 mg (CRC)
n=20 Participants
Participants with colorectal cancer (CRC) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1B BMS-986207 80 mg + Nivolumab 240 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
Part 1B BMS-986207 240 mg + Nivolumab 240 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
Part 1B BMS-986207 1600 mg + Nivolumab 480 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Part 1B: BMS-986207 480 mg + Nivolumab 480 mg
n=18 Participants
Participants with CRC or ovarian cancer or hepatocellular carcinoma were administered with 480 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Part 1C BMS-986207 1200 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
n=6 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with Nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and Ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the Nivolumab infusion.
Part 1C BMS-986207 600 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
n=18 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Part 2C BMS-986207 600 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
n=5 Participants
Participants with first-line non-small cell lung cancer were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Total
n=101 Participants
Total of all reporting groups
Age, Continuous
55.0 years
n=93 Participants
70.0 years
STANDARD_DEVIATION 2.83 • n=4 Participants
61.0 years
STANDARD_DEVIATION 6.24 • n=27 Participants
65.5 years
STANDARD_DEVIATION 12.61 • n=483 Participants
56.4 years
STANDARD_DEVIATION 13.99 • n=36 Participants
59.3 years
STANDARD_DEVIATION 9.43 • n=10 Participants
60.1 years
STANDARD_DEVIATION 10.16 • n=115 Participants
66.5 years
STANDARD_DEVIATION 3.11 • n=40 Participants
48.8 years
STANDARD_DEVIATION 8.85 • n=8 Participants
56.3 years
STANDARD_DEVIATION 19.57 • n=62 Participants
63.9 years
STANDARD_DEVIATION 13.19 • n=95 Participants
67.8 years
STANDARD_DEVIATION 10.03 • n=129 Participants
56.9 years
STANDARD_DEVIATION 12.68 • n=36 Participants
67.4 years
STANDARD_DEVIATION 8.91 • n=36 Participants
60.7 years
STANDARD_DEVIATION 11.96 • n=24 Participants
Sex: Female, Male
Female
1 Participants
n=93 Participants
2 Participants
n=4 Participants
2 Participants
n=27 Participants
2 Participants
n=483 Participants
4 Participants
n=36 Participants
2 Participants
n=10 Participants
9 Participants
n=115 Participants
3 Participants
n=40 Participants
1 Participants
n=8 Participants
2 Participants
n=62 Participants
4 Participants
n=95 Participants
3 Participants
n=129 Participants
9 Participants
n=36 Participants
1 Participants
n=36 Participants
45 Participants
n=24 Participants
Sex: Female, Male
Male
0 Participants
n=93 Participants
0 Participants
n=4 Participants
1 Participants
n=27 Participants
2 Participants
n=483 Participants
4 Participants
n=36 Participants
2 Participants
n=10 Participants
11 Participants
n=115 Participants
1 Participants
n=40 Participants
3 Participants
n=8 Participants
2 Participants
n=62 Participants
14 Participants
n=95 Participants
3 Participants
n=129 Participants
9 Participants
n=36 Participants
4 Participants
n=36 Participants
56 Participants
n=24 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
0 Participants
n=483 Participants
0 Participants
n=36 Participants
0 Participants
n=10 Participants
2 Participants
n=115 Participants
0 Participants
n=40 Participants
0 Participants
n=8 Participants
0 Participants
n=62 Participants
0 Participants
n=95 Participants
1 Participants
n=129 Participants
2 Participants
n=36 Participants
1 Participants
n=36 Participants
6 Participants
n=24 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
1 Participants
n=93 Participants
2 Participants
n=4 Participants
3 Participants
n=27 Participants
3 Participants
n=483 Participants
5 Participants
n=36 Participants
3 Participants
n=10 Participants
11 Participants
n=115 Participants
3 Participants
n=40 Participants
3 Participants
n=8 Participants
3 Participants
n=62 Participants
16 Participants
n=95 Participants
4 Participants
n=129 Participants
15 Participants
n=36 Participants
1 Participants
n=36 Participants
73 Participants
n=24 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
1 Participants
n=483 Participants
3 Participants
n=36 Participants
1 Participants
n=10 Participants
7 Participants
n=115 Participants
1 Participants
n=40 Participants
1 Participants
n=8 Participants
1 Participants
n=62 Participants
2 Participants
n=95 Participants
1 Participants
n=129 Participants
1 Participants
n=36 Participants
3 Participants
n=36 Participants
22 Participants
n=24 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
0 Participants
n=483 Participants
0 Participants
n=36 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=40 Participants
0 Participants
n=8 Participants
0 Participants
n=62 Participants
0 Participants
n=95 Participants
0 Participants
n=129 Participants
0 Participants
n=36 Participants
0 Participants
n=36 Participants
0 Participants
n=24 Participants
Race (NIH/OMB)
Asian
0 Participants
n=93 Participants
0 Participants
n=4 Participants
1 Participants
n=27 Participants
0 Participants
n=483 Participants
2 Participants
n=36 Participants
1 Participants
n=10 Participants
3 Participants
n=115 Participants
0 Participants
n=40 Participants
1 Participants
n=8 Participants
2 Participants
n=62 Participants
1 Participants
n=95 Participants
1 Participants
n=129 Participants
10 Participants
n=36 Participants
0 Participants
n=36 Participants
22 Participants
n=24 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
0 Participants
n=483 Participants
0 Participants
n=36 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=40 Participants
0 Participants
n=8 Participants
0 Participants
n=62 Participants
0 Participants
n=95 Participants
0 Participants
n=129 Participants
0 Participants
n=36 Participants
0 Participants
n=36 Participants
0 Participants
n=24 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
0 Participants
n=483 Participants
0 Participants
n=36 Participants
0 Participants
n=10 Participants
1 Participants
n=115 Participants
0 Participants
n=40 Participants
0 Participants
n=8 Participants
0 Participants
n=62 Participants
1 Participants
n=95 Participants
2 Participants
n=129 Participants
0 Participants
n=36 Participants
0 Participants
n=36 Participants
4 Participants
n=24 Participants
Race (NIH/OMB)
White
1 Participants
n=93 Participants
2 Participants
n=4 Participants
2 Participants
n=27 Participants
4 Participants
n=483 Participants
6 Participants
n=36 Participants
3 Participants
n=10 Participants
15 Participants
n=115 Participants
4 Participants
n=40 Participants
3 Participants
n=8 Participants
2 Participants
n=62 Participants
16 Participants
n=95 Participants
2 Participants
n=129 Participants
7 Participants
n=36 Participants
5 Participants
n=36 Participants
72 Participants
n=24 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
0 Participants
n=483 Participants
0 Participants
n=36 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=40 Participants
0 Participants
n=8 Participants
0 Participants
n=62 Participants
0 Participants
n=95 Participants
0 Participants
n=129 Participants
0 Participants
n=36 Participants
0 Participants
n=36 Participants
0 Participants
n=24 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
0 Participants
n=483 Participants
0 Participants
n=36 Participants
0 Participants
n=10 Participants
1 Participants
n=115 Participants
0 Participants
n=40 Participants
0 Participants
n=8 Participants
0 Participants
n=62 Participants
0 Participants
n=95 Participants
1 Participants
n=129 Participants
1 Participants
n=36 Participants
0 Participants
n=36 Participants
3 Participants
n=24 Participants

PRIMARY outcome

Timeframe: From first dose (Day 1) untill 100 days after last dose (Up to approximately 27 months)

Population: All Treated Participants.

An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization.

Outcome measures

Outcome measures
Measure
Part 1A BMS-986207 Safety Run In
n=1 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with total 48 mg of BMS-986207 as 60 minutes intravenous infusion in one cycle (each cycle of 8 weeks).
Part 1A BMS-986207 20 mg
n=2 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 20 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 80 mg
n=3 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 240 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 800 mg
n=8 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 1600 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w) or 2 doses of BMS-986207 administered every 4 weeks (q4w).
Part 2A BMS-986207 800 mg (CRC)
n=20 Participants
Participants with colorectal cancer (CRC) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1B BMS-986207 80 mg + Nivolumab 240 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
Part 1B BMS-986207 240 mg + Nivolumab 240 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
Part 1B BMS-986207 1600 mg + Nivolumab 480 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Part 1B: BMS-986207 480 mg + Nivolumab 480 mg
n=18 Participants
Participants with CRC or ovarian cancer or hepatocellular carcinoma were administered with 480 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Part 1C BMS-986207 1200 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
n=6 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with Nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and Ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the Nivolumab infusion.
Part 1C BMS-986207 600 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
n=18 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Part 2C BMS-986207 600 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
n=5 Participants
Participants with first-line non-small cell lung cancer were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Number of Participants With Adverse Events
Participants with any Adverse Events
1 Participants
2 Participants
3 Participants
4 Participants
8 Participants
4 Participants
20 Participants
4 Participants
4 Participants
4 Participants
18 Participants
6 Participants
18 Participants
5 Participants
Number of Participants With Adverse Events
Participants with Serious Adverse Events
1 Participants
0 Participants
3 Participants
3 Participants
5 Participants
1 Participants
11 Participants
3 Participants
2 Participants
1 Participants
6 Participants
4 Participants
11 Participants
5 Participants
Number of Participants With Adverse Events
AEs leading to treatment discontinuation
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
1 Participants
1 Participants
3 Participants
3 Participants

PRIMARY outcome

Timeframe: From first dose (Day 1) untill 100 days after last dose (Up to approximately 27 months)

Population: All Treated Participants.

Participants who died with any cause are considered in the analysis.

Outcome measures

Outcome measures
Measure
Part 1A BMS-986207 Safety Run In
n=1 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with total 48 mg of BMS-986207 as 60 minutes intravenous infusion in one cycle (each cycle of 8 weeks).
Part 1A BMS-986207 20 mg
n=2 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 20 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 80 mg
n=3 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 240 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 800 mg
n=8 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 1600 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w) or 2 doses of BMS-986207 administered every 4 weeks (q4w).
Part 2A BMS-986207 800 mg (CRC)
n=20 Participants
Participants with colorectal cancer (CRC) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1B BMS-986207 80 mg + Nivolumab 240 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
Part 1B BMS-986207 240 mg + Nivolumab 240 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
Part 1B BMS-986207 1600 mg + Nivolumab 480 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Part 1B: BMS-986207 480 mg + Nivolumab 480 mg
n=18 Participants
Participants with CRC or ovarian cancer or hepatocellular carcinoma were administered with 480 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Part 1C BMS-986207 1200 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
n=6 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with Nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and Ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the Nivolumab infusion.
Part 1C BMS-986207 600 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
n=18 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Part 2C BMS-986207 600 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
n=5 Participants
Participants with first-line non-small cell lung cancer were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Number of Participants Who Died
1 Participants
0 Participants
3 Participants
1 Participants
1 Participants
1 Participants
8 Participants
2 Participants
2 Participants
1 Participants
1 Participants
1 Participants
3 Participants
1 Participants

PRIMARY outcome

Timeframe: From first dose (Day 1) and up to 6 weeks

Population: All Treated Participants. Pre-specified to be only collected for Part 1A, 1B, 1C and 2A arms.

Criteria for Dose-Limiting Toxicities (DLTs): Hepatic DLTs (excluding HCC): Grade (Gr) 4 elevations in AST, ALT, ALP, or total bilirubin. Gr 3 elevations in AST, ALT, or ALP \>5 days, with symptoms, or bilirubin \>2xULN without cholestasis. Gr 2 AST or ALT with symptomatic liver inflammation. AST or ALT \>3xULN and bilirubin \>2xULN without cholestasis. Hepatic DLTs for HCC: AST or ALT \>10xULN for \>2 weeks. AST or ALT \>15xULN. Total bilirubin \>8xULN (elevated at entry) or \>5xULN (normal at entry). ALT ≥10xULN and bilirubin ≥2xULN or baseline, without other causes. Hematologic DLTs: Gr 4 neutropenia ≥7 days. Gr 4 thrombocytopenia. Gr 3 thrombocytopenia with bleeding or platelet transfusion. Febrile neutropenia. Gr 3 hemolysis requiring intervention. Gr 4 anemia not due to underlying disease. Dermatologic DLTs: Gr 4 rash. Gr 3 rash not improving to ≤Gr 1 after 1-2 week delay. Other DLTs: Gr 2-4 eye issues, Gr 3-4 toxicities, excluding specific Gr 3 events like nausea, fever.

Outcome measures

Outcome measures
Measure
Part 1A BMS-986207 Safety Run In
n=1 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with total 48 mg of BMS-986207 as 60 minutes intravenous infusion in one cycle (each cycle of 8 weeks).
Part 1A BMS-986207 20 mg
n=2 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 20 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 80 mg
n=3 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 240 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 800 mg
n=8 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 1600 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w) or 2 doses of BMS-986207 administered every 4 weeks (q4w).
Part 2A BMS-986207 800 mg (CRC)
n=20 Participants
Participants with colorectal cancer (CRC) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1B BMS-986207 80 mg + Nivolumab 240 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
Part 1B BMS-986207 240 mg + Nivolumab 240 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
Part 1B BMS-986207 1600 mg + Nivolumab 480 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Part 1B: BMS-986207 480 mg + Nivolumab 480 mg
n=18 Participants
Participants with CRC or ovarian cancer or hepatocellular carcinoma were administered with 480 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Part 1C BMS-986207 1200 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
n=6 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with Nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and Ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the Nivolumab infusion.
Part 1C BMS-986207 600 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
n=18 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Part 2C BMS-986207 600 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
Participants with first-line non-small cell lung cancer were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Part 1A, 1B and 1C and 2A: Number of Participants With Dose Limiting Toxicities
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
2 Participants
1 Participants

PRIMARY outcome

Timeframe: From first dose (Day 1) till 100 days after last dose (Up to approximately 27 months)

Population: All treated participants with available laboratory abnormality results. Pre-specified to be only collected for Part 1A, 1B, 1C and 2A arms.

Blood samples were collected to assess the abnormalities in laboratory parameters. The laboratory parameters were graded by Common Terminology Criteria for Adverse Events (CTCAE). Grade 3=Severe; Grade 4=Life-threatening.

Outcome measures

Outcome measures
Measure
Part 1A BMS-986207 Safety Run In
n=1 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with total 48 mg of BMS-986207 as 60 minutes intravenous infusion in one cycle (each cycle of 8 weeks).
Part 1A BMS-986207 20 mg
n=2 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 20 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 80 mg
n=3 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 240 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 800 mg
n=8 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 1600 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w) or 2 doses of BMS-986207 administered every 4 weeks (q4w).
Part 2A BMS-986207 800 mg (CRC)
n=20 Participants
Participants with colorectal cancer (CRC) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1B BMS-986207 80 mg + Nivolumab 240 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
Part 1B BMS-986207 240 mg + Nivolumab 240 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
Part 1B BMS-986207 1600 mg + Nivolumab 480 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Part 1B: BMS-986207 480 mg + Nivolumab 480 mg
n=18 Participants
Participants with CRC or ovarian cancer or hepatocellular carcinoma were administered with 480 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Part 1C BMS-986207 1200 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
n=6 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with Nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and Ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the Nivolumab infusion.
Part 1C BMS-986207 600 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
n=18 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Part 2C BMS-986207 600 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
Participants with first-line non-small cell lung cancer were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities
NEUTROPHILS (ABSOLUTE) (Grade 3)
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities
NEUTROPHILS (ABSOLUTE) (Grade 4)
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities
PLATELET COUNT (Grade 4)
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities
LEUKOCYTES (Grade 3)
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities
LEUKOCYTES (Grade 4)
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities
LYMPHOCYTES (ABSOLUTE) (Grade 3)
1 Participants
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
4 Participants
0 Participants
2 Participants
1 Participants
2 Participants
1 Participants
2 Participants
Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities
LYMPHOCYTES (ABSOLUTE) (Grade 4)
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities
ALKALINE PHOSPHATASE (Grade 3)
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
1 Participants
4 Participants
0 Participants
1 Participants
1 Participants
0 Participants
0 Participants
1 Participants
Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities
ALKALINE PHOSPHATASE (Grade 4)
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities
ASPARTATE AMINOTRANSFERASE (Grade 4)
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities
ALBUMIN (Grade 3)
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities
AMYLASE (Grade 3)
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities
AMYLASE (Grade 4)
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities
URIC ACID (Grade 3)
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities
HYPERCALCEMIA (Grade 3)
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities
HYPOCALCEMIA (Grade 3)
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities
HYPERMAGNESEMIA (Grade 4)
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities
HYPOMAGNESEMIA (Grade 3)
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities
HYPOMAGNESEMIA (Grade 4)
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities
HYPERKALEMIA (Grade 3)
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities
HEMOGLOBIN (Grade 3)
0 Participants
0 Participants
0 Participants
0 Participants
2 Participants
0 Participants
1 Participants
1 Participants
2 Participants
1 Participants
0 Participants
0 Participants
2 Participants
Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities
PLATELET COUNT (Grade 3)
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities
ABSOLUTE NEUTROPHIL COUNT (Grade 3)
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities
ABSOLUTE NEUTROPHIL COUNT (Grade 4)
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities
APTT (Grade 3)
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities
APTT (Grade 4)
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities
ASPARTATE AMINOTRANSFERASE (Grade 3)
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities
ALANINE AMINOTRANSFERASE (Grade 3)
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities
ALANINE AMINOTRANSFERASE (Grade 4)
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities
G-GLUTAMYL TRANSFERASE (Grade 3)
0 Participants
0 Participants
1 Participants
0 Participants
2 Participants
0 Participants
7 Participants
0 Participants
1 Participants
2 Participants
0 Participants
1 Participants
3 Participants
Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities
G-GLUTAMYL TRANSFERASE (Grade 4)
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities
BILIRUBIN, TOTAL (Grade 3)
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
2 Participants
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
1 Participants
Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities
BILIRUBIN, TOTAL (Grade 4)
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities
CREATININE (Grade 3)
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities
CREATININE (Grade 4)
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities
CALCIUM (Grade 3)
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities
CALCIUM (Grade 4)
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities
PHOSPHORUS (Grade 3)
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities
PHOSPHORUS (Grade 4)
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities
ALBUMIN (Grade 4)
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities
LIPASE (Grade 3)
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
2 Participants
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
2 Participants
Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities
LIPASE (Grade 4)
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities
URIC ACID (Grade 4)
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
1 Participants
0 Participants
1 Participants
0 Participants
0 Participants
Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities
HYPERNATREMIA (Grade 3)
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities
HYPERNATREMIA (Grade 4)
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities
HYPONATREMIA (Grade 3)
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
1 Participants
0 Participants
1 Participants
4 Participants
Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities
HYPONATREMIA (Grade 4)
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities
HYPERKALEMIA (Grade 4)
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities
HYPOKALEMIA (Grade 3)
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities
HYPOKALEMIA (Grade 4)
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities
HYPERCALCEMIA (Grade 4)
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities
HYPOCALCEMIA (Grade 4)
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities
HYPERMAGNESEMIA (Grade 3)
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: From first dose (Day 1) and up to 24 weeks

Population: All Treated Participants.

ORR is defined as the percentage of participants with a confirmed Best overall response of Complete Response (CR) or Partial Response (PR) by RECIST v1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Outcome measures
Measure
Part 1A BMS-986207 Safety Run In
n=5 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with total 48 mg of BMS-986207 as 60 minutes intravenous infusion in one cycle (each cycle of 8 weeks).
Part 1A BMS-986207 20 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 20 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 80 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 800 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 1600 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w) or 2 doses of BMS-986207 administered every 4 weeks (q4w).
Part 2A BMS-986207 800 mg (CRC)
Participants with colorectal cancer (CRC) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1B BMS-986207 80 mg + Nivolumab 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
Part 1B BMS-986207 240 mg + Nivolumab 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
Part 1B BMS-986207 1600 mg + Nivolumab 480 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Part 1B: BMS-986207 480 mg + Nivolumab 480 mg
Participants with CRC or ovarian cancer or hepatocellular carcinoma were administered with 480 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Part 1C BMS-986207 1200 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with Nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and Ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the Nivolumab infusion.
Part 1C BMS-986207 600 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Part 2C BMS-986207 600 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
Participants with first-line non-small cell lung cancer were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Part 2C: Objective Response Rate (ORR)
20.0 percentage of participants
Interval 0.5 to 71.6

PRIMARY outcome

Timeframe: From first dose (Day 1) and up to 24 weeks

Population: All Treated Participants. Participants with CR or PR were included in the analysis.

DOR is defined for participants who have a confirmed CR or PR as the date from first documented CR or PR per RECIST v1.1 to the date of the documentation of disease progression or death due to any cause, whichever is earlier. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Outcome measures
Measure
Part 1A BMS-986207 Safety Run In
n=1 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with total 48 mg of BMS-986207 as 60 minutes intravenous infusion in one cycle (each cycle of 8 weeks).
Part 1A BMS-986207 20 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 20 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 80 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 800 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 1600 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w) or 2 doses of BMS-986207 administered every 4 weeks (q4w).
Part 2A BMS-986207 800 mg (CRC)
Participants with colorectal cancer (CRC) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1B BMS-986207 80 mg + Nivolumab 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
Part 1B BMS-986207 240 mg + Nivolumab 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
Part 1B BMS-986207 1600 mg + Nivolumab 480 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Part 1B: BMS-986207 480 mg + Nivolumab 480 mg
Participants with CRC or ovarian cancer or hepatocellular carcinoma were administered with 480 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Part 1C BMS-986207 1200 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with Nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and Ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the Nivolumab infusion.
Part 1C BMS-986207 600 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Part 2C BMS-986207 600 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
Participants with first-line non-small cell lung cancer were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Part 2C: Duration of Response (DOR)
NA months
Not estimated due to inadequate number of events.

PRIMARY outcome

Timeframe: Week 24

Population: All Treated Participants.

Progression Free Survival Rates at 24 weeks is defined as the percentage of participants who achieve PFS at 24 weeks. PFS for a participant is defined as the time from randomization date to the date of first objectively documented disease progression by investigator per response evaluation criteria in solid tumors (RECIST) v1.1 or death due to any cause, whichever occurs first. Based on Kaplan-Meier Estimates. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

Outcome measures

Outcome measures
Measure
Part 1A BMS-986207 Safety Run In
n=5 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with total 48 mg of BMS-986207 as 60 minutes intravenous infusion in one cycle (each cycle of 8 weeks).
Part 1A BMS-986207 20 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 20 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 80 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 800 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 1600 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w) or 2 doses of BMS-986207 administered every 4 weeks (q4w).
Part 2A BMS-986207 800 mg (CRC)
Participants with colorectal cancer (CRC) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1B BMS-986207 80 mg + Nivolumab 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
Part 1B BMS-986207 240 mg + Nivolumab 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
Part 1B BMS-986207 1600 mg + Nivolumab 480 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Part 1B: BMS-986207 480 mg + Nivolumab 480 mg
Participants with CRC or ovarian cancer or hepatocellular carcinoma were administered with 480 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Part 1C BMS-986207 1200 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with Nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and Ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the Nivolumab infusion.
Part 1C BMS-986207 600 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Part 2C BMS-986207 600 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
Participants with first-line non-small cell lung cancer were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Part 2C: Progression Free Survival Rate at Week 24
80.0 percentage of participants
Interval 20.4 to 96.9

SECONDARY outcome

Timeframe: From first dose (Day 1) and up to 24 weeks

Population: All Treated Participants.

ORR is defined as the percentage of participants with a confirmed Best overall response of Complete Response (CR) or Partial Response (PR) by RECIST v1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters

Outcome measures

Outcome measures
Measure
Part 1A BMS-986207 Safety Run In
n=1 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with total 48 mg of BMS-986207 as 60 minutes intravenous infusion in one cycle (each cycle of 8 weeks).
Part 1A BMS-986207 20 mg
n=2 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 20 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 80 mg
n=3 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 240 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 800 mg
n=8 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 1600 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w) or 2 doses of BMS-986207 administered every 4 weeks (q4w).
Part 2A BMS-986207 800 mg (CRC)
n=20 Participants
Participants with colorectal cancer (CRC) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1B BMS-986207 80 mg + Nivolumab 240 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
Part 1B BMS-986207 240 mg + Nivolumab 240 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
Part 1B BMS-986207 1600 mg + Nivolumab 480 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Part 1B: BMS-986207 480 mg + Nivolumab 480 mg
n=18 Participants
Participants with CRC or ovarian cancer or hepatocellular carcinoma were administered with 480 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Part 1C BMS-986207 1200 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
n=6 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with Nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and Ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the Nivolumab infusion.
Part 1C BMS-986207 600 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
n=18 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Part 2C BMS-986207 600 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
Participants with first-line non-small cell lung cancer were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Objective Response Rate (ORR)
0.0 percentage of participants
Interval 0.0 to 97.5
0.0 percentage of participants
Interval 0.0 to 84.2
0.0 percentage of participants
Interval 0.0 to 70.8
0.0 percentage of participants
Interval 0.0 to 60.2
0.0 percentage of participants
Interval 0.0 to 36.9
0.0 percentage of participants
Interval 0.0 to 60.2
0.0 percentage of participants
Interval 0.0 to 16.8
0.0 percentage of participants
Interval 0.0 to 60.2
0.0 percentage of participants
Interval 0.0 to 60.2
0.0 percentage of participants
Interval 0.0 to 60.2
22.2 percentage of participants
Interval 6.4 to 47.6
33.3 percentage of participants
Interval 4.3 to 77.7
5.6 percentage of participants
Interval 0.1 to 27.3

SECONDARY outcome

Timeframe: From first dose (Day 1) and up to 24 weeks

Population: All Treated Participants. Participants with CR or PR were included in the analysis.

DOR is defined for participants who have a confirmed CR or PR as the date from first documented CR or PR per RECIST v1.1 to the date of the documentation of disease progression or death due to any cause, whichever is earlier. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Outcome measures
Measure
Part 1A BMS-986207 Safety Run In
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with total 48 mg of BMS-986207 as 60 minutes intravenous infusion in one cycle (each cycle of 8 weeks).
Part 1A BMS-986207 20 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 20 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 80 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 800 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 1600 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w) or 2 doses of BMS-986207 administered every 4 weeks (q4w).
Part 2A BMS-986207 800 mg (CRC)
Participants with colorectal cancer (CRC) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1B BMS-986207 80 mg + Nivolumab 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
Part 1B BMS-986207 240 mg + Nivolumab 240 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
Part 1B BMS-986207 1600 mg + Nivolumab 480 mg
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Part 1B: BMS-986207 480 mg + Nivolumab 480 mg
n=4 Participants
Participants with CRC or ovarian cancer or hepatocellular carcinoma were administered with 480 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Part 1C BMS-986207 1200 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
n=2 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with Nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and Ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the Nivolumab infusion.
Part 1C BMS-986207 600 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
n=1 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Part 2C BMS-986207 600 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
Participants with first-line non-small cell lung cancer were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Duration of Response
NA percentage of participants
Not evaluable due to inadequate number of events
NA percentage of participants
Not evaluable due to inadequate number of events
NA percentage of participants
Not evaluable due to inadequate number of events

SECONDARY outcome

Timeframe: Week 24

Population: All Treated Participants.

Progression Free Survival Rates at 24 weeks is defined as the percentage of participants who achieve PFS at 24 weeks. PFS for a participant is defined as the time from randomization date to the date of first objectively documented disease progression by investigator per response evaluation criteria in solid tumors (RECIST) v1.1 or death due to any cause, whichever occurs first. Based on Kaplan-Meier Estimates. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

Outcome measures

Outcome measures
Measure
Part 1A BMS-986207 Safety Run In
n=1 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with total 48 mg of BMS-986207 as 60 minutes intravenous infusion in one cycle (each cycle of 8 weeks).
Part 1A BMS-986207 20 mg
n=2 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 20 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 80 mg
n=3 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 240 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 800 mg
n=8 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 1600 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w) or 2 doses of BMS-986207 administered every 4 weeks (q4w).
Part 2A BMS-986207 800 mg (CRC)
n=20 Participants
Participants with colorectal cancer (CRC) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1B BMS-986207 80 mg + Nivolumab 240 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
Part 1B BMS-986207 240 mg + Nivolumab 240 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
Part 1B BMS-986207 1600 mg + Nivolumab 480 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Part 1B: BMS-986207 480 mg + Nivolumab 480 mg
n=18 Participants
Participants with CRC or ovarian cancer or hepatocellular carcinoma were administered with 480 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Part 1C BMS-986207 1200 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
n=6 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with Nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and Ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the Nivolumab infusion.
Part 1C BMS-986207 600 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
n=18 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Part 2C BMS-986207 600 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
Participants with first-line non-small cell lung cancer were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Progression Free Survival Rate at Week 24
100.0 percentage of participants
Interval 100.0 to 100.0
100.0 percentage of participants
Interval 100.0 to 100.0
66.7 percentage of participants
Interval 5.4 to 94.5
100.0 percentage of participants
Interval 100.0 to 100.0
75.0 percentage of participants
Interval 31.5 to 93.1
100.0 percentage of participants
Interval 100.0 to 100.0
70.0 percentage of participants
Interval 45.1 to 85.3
100.0 percentage of participants
Interval 100.0 to 100.0
100.0 percentage of participants
Interval 100.0 to 100.0
75.0 percentage of participants
Interval 12.8 to 96.1
93.3 percentage of participants
Interval 61.3 to 99.0
66.7 percentage of participants
Interval 19.5 to 90.4
61.1 percentage of participants
Interval 35.3 to 79.2

SECONDARY outcome

Timeframe: Day 1 of Cycle 1, Cycle 2 and Cycle 3 (Each cycle is of 8 weeks)

Population: All treated participants who have evaluable concentration-time data were included in the analysis. Only participants with evaluable concentration-time data at particular timepoint are considered in the analysis. Participant in Part 1A BMS-986207 Safety Run In did not meet criteria of evaluable concentration-time data hence not included in the analysis.

Cmax is defined as maximum plasma concentration of the drug.

Outcome measures

Outcome measures
Measure
Part 1A BMS-986207 Safety Run In
n=2 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with total 48 mg of BMS-986207 as 60 minutes intravenous infusion in one cycle (each cycle of 8 weeks).
Part 1A BMS-986207 20 mg
n=3 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 20 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 80 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 240 mg
n=8 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 800 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 1600 mg
n=20 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w) or 2 doses of BMS-986207 administered every 4 weeks (q4w).
Part 2A BMS-986207 800 mg (CRC)
n=4 Participants
Participants with colorectal cancer (CRC) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1B BMS-986207 80 mg + Nivolumab 240 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
Part 1B BMS-986207 240 mg + Nivolumab 240 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
Part 1B BMS-986207 1600 mg + Nivolumab 480 mg
n=18 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Part 1B: BMS-986207 480 mg + Nivolumab 480 mg
n=6 Participants
Participants with CRC or ovarian cancer or hepatocellular carcinoma were administered with 480 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Part 1C BMS-986207 1200 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
n=18 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with Nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and Ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the Nivolumab infusion.
Part 1C BMS-986207 600 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
n=5 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Part 2C BMS-986207 600 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
Participants with first-line non-small cell lung cancer were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Maximum Observed Concentration (Cmax) of BMS-986207
Cycle 2 Day 1
7540 ng/mL
Geometric Coefficient of Variation NA
Not evaluable due to inadequate number of participants analyzed
41200 ng/mL
Geometric Coefficient of Variation NA
Not evaluable due to inadequate number of participants analyzed
112632 ng/mL
Geometric Coefficient of Variation 36
349009 ng/mL
Geometric Coefficient of Variation 28
646106 ng/mL
Geometric Coefficient of Variation 7
351683 ng/mL
Geometric Coefficient of Variation 29
33291 ng/mL
Geometric Coefficient of Variation 18
73100 ng/mL
Geometric Coefficient of Variation NA
Not evaluable due to inadequate number of participants analyzed
Maximum Observed Concentration (Cmax) of BMS-986207
Cycle 1 Day 1
4952 ng/mL
Geometric Coefficient of Variation 34
27291 ng/mL
Geometric Coefficient of Variation 11
78548 ng/mL
Geometric Coefficient of Variation 29
249112 ng/mL
Geometric Coefficient of Variation 16
439192 ng/mL
Geometric Coefficient of Variation 15
259914 ng/mL
Geometric Coefficient of Variation 27
48703 ng/mL
Geometric Coefficient of Variation 86
67136 ng/mL
Geometric Coefficient of Variation 31
510696 ng/mL
Geometric Coefficient of Variation 29
124997 ng/mL
Geometric Coefficient of Variation 27
446640 ng/mL
Geometric Coefficient of Variation 20
215247 ng/mL
Geometric Coefficient of Variation 31
257979 ng/mL
Geometric Coefficient of Variation 35
Maximum Observed Concentration (Cmax) of BMS-986207
Cycle 3 Day 1
486000 ng/mL
Geometric Coefficient of Variation NA
Not evaluable due to inadequate number of participants analyzed
165211 ng/mL
Geometric Coefficient of Variation 20
442029 ng/mL
Geometric Coefficient of Variation 41
272349 ng/mL
Geometric Coefficient of Variation 65
322580 ng/mL
Geometric Coefficient of Variation 40

SECONDARY outcome

Timeframe: Day 1 of Cycle 1, Cycle 2 and Cycle 3 (Each cycle is of 8 weeks)

Population: All treated participants who have evaluable concentration-time data were included in the analysis. Only participants with evaluable concentration-time data at particular timepoint are considered in the analysis. Participant in Part 1A BMS-986207 Safety Run In did not meet criteria of evaluable concentration-time data hence not included in the analysis.

Time to observed maximum concentration (Tmax) is defined as the amount of time in hours for a drug to reach the maximum concentration after administration.

Outcome measures

Outcome measures
Measure
Part 1A BMS-986207 Safety Run In
n=2 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with total 48 mg of BMS-986207 as 60 minutes intravenous infusion in one cycle (each cycle of 8 weeks).
Part 1A BMS-986207 20 mg
n=3 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 20 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 80 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 240 mg
n=8 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 800 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 1600 mg
n=20 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w) or 2 doses of BMS-986207 administered every 4 weeks (q4w).
Part 2A BMS-986207 800 mg (CRC)
n=4 Participants
Participants with colorectal cancer (CRC) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1B BMS-986207 80 mg + Nivolumab 240 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
Part 1B BMS-986207 240 mg + Nivolumab 240 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
Part 1B BMS-986207 1600 mg + Nivolumab 480 mg
n=18 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Part 1B: BMS-986207 480 mg + Nivolumab 480 mg
n=6 Participants
Participants with CRC or ovarian cancer or hepatocellular carcinoma were administered with 480 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Part 1C BMS-986207 1200 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
n=18 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with Nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and Ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the Nivolumab infusion.
Part 1C BMS-986207 600 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
n=5 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Part 2C BMS-986207 600 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
Participants with first-line non-small cell lung cancer were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
BMS-986207 Time to Maximum Concentration (Tmax)
Cycle 1 Day 1
2.20 hours
Geometric Coefficient of Variation 169
1.07 hours
Geometric Coefficient of Variation 9
1.00 hours
Geometric Coefficient of Variation 5
1.29 hours
Geometric Coefficient of Variation 59
1.59 hours
Geometric Coefficient of Variation 72
1.11 hours
Geometric Coefficient of Variation 31
9.63 hours
Geometric Coefficient of Variation 3383
0.962 hours
Geometric Coefficient of Variation 5
1.47 hours
Geometric Coefficient of Variation 75
1.63 hours
Geometric Coefficient of Variation 110
1.94 hours
Geometric Coefficient of Variation 50
1.53 hours
Geometric Coefficient of Variation 62
1.64 hours
Geometric Coefficient of Variation 23
BMS-986207 Time to Maximum Concentration (Tmax)
Cycle 2 Day 1
5.00 hours
Geometric Coefficient of Variation NA
Not evaluable due to inadequate number of participants analyzed
0.983 hours
Geometric Coefficient of Variation NA
Not evaluable due to inadequate number of participants analyzed
0.989 hours
Geometric Coefficient of Variation 3
4.92 hours
Geometric Coefficient of Variation 515
10.0 hours
Geometric Coefficient of Variation 190
4.08 hours
Geometric Coefficient of Variation 291
2.51 hours
Geometric Coefficient of Variation 96
1.00 hours
Geometric Coefficient of Variation NA
Not evaluable due to inadequate number of participants analyzed
BMS-986207 Time to Maximum Concentration (Tmax)
Cycle 3 Day 1
3.98 hours
Geometric Coefficient of Variation NA
Not evaluable due to inadequate number of participants analyzed
1.88 hours
Geometric Coefficient of Variation 82
1.00 hours
Geometric Coefficient of Variation 0
1.03 hours
Geometric Coefficient of Variation 9
1.42 hours
Geometric Coefficient of Variation 37

SECONDARY outcome

Timeframe: Day 1 of Cycle 1, Cycle 2 and Cycle 3 (Each cycle is of 8 weeks)

Population: All treated participants who have evaluable concentration-time data were included in the analysis. Only participants with evaluable concentration-time data at particular timepoint are considered in the analysis. Participant in Part 1A BMS-986207 Safety Run In did not meet criteria of evaluable concentration-time data hence not included in the analysis.

BMS-986207 area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC (0-T)).

Outcome measures

Outcome measures
Measure
Part 1A BMS-986207 Safety Run In
n=2 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with total 48 mg of BMS-986207 as 60 minutes intravenous infusion in one cycle (each cycle of 8 weeks).
Part 1A BMS-986207 20 mg
n=3 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 20 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 80 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 240 mg
n=8 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 800 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 1600 mg
n=20 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w) or 2 doses of BMS-986207 administered every 4 weeks (q4w).
Part 2A BMS-986207 800 mg (CRC)
n=4 Participants
Participants with colorectal cancer (CRC) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1B BMS-986207 80 mg + Nivolumab 240 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
Part 1B BMS-986207 240 mg + Nivolumab 240 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
Part 1B BMS-986207 1600 mg + Nivolumab 480 mg
n=18 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Part 1B: BMS-986207 480 mg + Nivolumab 480 mg
n=6 Participants
Participants with CRC or ovarian cancer or hepatocellular carcinoma were administered with 480 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Part 1C BMS-986207 1200 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
n=18 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with Nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and Ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the Nivolumab infusion.
Part 1C BMS-986207 600 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
n=5 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Part 2C BMS-986207 600 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
Participants with first-line non-small cell lung cancer were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
BMS-986207 Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC (0-T))
Cycle 1 Day 1
903246 h*ng/mL
Geometric Coefficient of Variation 16
4040645 h*ng/mL
Geometric Coefficient of Variation 20
11778859 h*ng/mL
Geometric Coefficient of Variation 27
39736190 h*ng/mL
Geometric Coefficient of Variation 26
66647788 h*ng/mL
Geometric Coefficient of Variation 15
33053505 h*ng/mL
Geometric Coefficient of Variation 37
4954133 h*ng/mL
Geometric Coefficient of Variation 63
7568790 h*ng/mL
Geometric Coefficient of Variation 58
103780934 h*ng/mL
Geometric Coefficient of Variation 21
26213882 h*ng/mL
Geometric Coefficient of Variation 34
55152586 h*ng/mL
Geometric Coefficient of Variation 79
34199336 h*ng/mL
Geometric Coefficient of Variation 38
38608827 h*ng/mL
Geometric Coefficient of Variation 34
BMS-986207 Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC (0-T))
Cycle 2 Day 1
1433844 h*ng/mL
Geometric Coefficient of Variation NA
Not evaluable due to inadequate number of participants analyzed
8631703 h*ng/mL
Geometric Coefficient of Variation NA
Not evaluable due to inadequate number of participants analyzed
21669222 h*ng/mL
Geometric Coefficient of Variation 46
79172947 h*ng/mL
Geometric Coefficient of Variation 31
151321351 h*ng/mL
Geometric Coefficient of Variation 17
74976626 h*ng/mL
Geometric Coefficient of Variation 45
5329459 h*ng/mL
Geometric Coefficient of Variation 43
16061212 h*ng/mL
Geometric Coefficient of Variation NA
Not evaluable due to inadequate number of participants analyzed
BMS-986207 Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC (0-T))
Cycle 3 Day 1
113248878 h*ng/mL
Geometric Coefficient of Variation NA
Not evaluable due to inadequate number of participants analyzed
42867360 h*ng/mL
Geometric Coefficient of Variation 24
133901271 h*ng/mL
Geometric Coefficient of Variation 49
56012897 h*ng/mL
Geometric Coefficient of Variation 46
53257007 h*ng/mL
Geometric Coefficient of Variation 82

SECONDARY outcome

Timeframe: Day 1 of Cycle 1, Cycle 2 and Cycle 3 (Each cycle is of 8 weeks)

Population: All treated participants who have evaluable concentration-time data were included in the analysis. Only participants with evaluable concentration-time data at particular timepoint are considered in the analysis. Participant in Part 1A BMS-986207 Safety Run In did not meet criteria of evaluable concentration-time data hence not included in the analysis.

Blood samples were collected for assessing AUC (TAU).

Outcome measures

Outcome measures
Measure
Part 1A BMS-986207 Safety Run In
n=2 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with total 48 mg of BMS-986207 as 60 minutes intravenous infusion in one cycle (each cycle of 8 weeks).
Part 1A BMS-986207 20 mg
n=3 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 20 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 80 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 240 mg
n=8 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 800 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 1600 mg
n=20 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w) or 2 doses of BMS-986207 administered every 4 weeks (q4w).
Part 2A BMS-986207 800 mg (CRC)
n=4 Participants
Participants with colorectal cancer (CRC) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1B BMS-986207 80 mg + Nivolumab 240 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
Part 1B BMS-986207 240 mg + Nivolumab 240 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
Part 1B BMS-986207 1600 mg + Nivolumab 480 mg
n=18 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Part 1B: BMS-986207 480 mg + Nivolumab 480 mg
n=6 Participants
Participants with CRC or ovarian cancer or hepatocellular carcinoma were administered with 480 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Part 1C BMS-986207 1200 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
n=18 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with Nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and Ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the Nivolumab infusion.
Part 1C BMS-986207 600 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
n=5 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Part 2C BMS-986207 600 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
Participants with first-line non-small cell lung cancer were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
BMS-986207 Area Under the Serum Concentration-time Curve in One Dosing Interval AUC (TAU)
Cycle 1 Day 1
903246 h*ng/mL
Geometric Coefficient of Variation 16
4040645 h*ng/mL
Geometric Coefficient of Variation 20
11778859 h*ng/mL
Geometric Coefficient of Variation 27
42372351 h*ng/mL
Geometric Coefficient of Variation 16
66647788 h*ng/mL
Geometric Coefficient of Variation 15
36019071 h*ng/mL
Geometric Coefficient of Variation 29
5436490 h*ng/mL
Geometric Coefficient of Variation 49
7962140 h*ng/mL
Geometric Coefficient of Variation 46
107854224 h*ng/mL
Geometric Coefficient of Variation 27
27192752 h*ng/mL
Geometric Coefficient of Variation 27
85887190 h*ng/mL
Geometric Coefficient of Variation 28
35370530 h*ng/mL
Geometric Coefficient of Variation 35
38608827 h*ng/mL
Geometric Coefficient of Variation 34
BMS-986207 Area Under the Serum Concentration-time Curve in One Dosing Interval AUC (TAU)
Cycle 2 Day 1
1433844 h*ng/mL
Geometric Coefficient of Variation NA
Not evaluable due to inadequate number of participants analyzed
8631703 h*ng/mL
Geometric Coefficient of Variation NA
Not evaluable due to inadequate number of participants analyzed
21669222 h*ng/mL
Geometric Coefficient of Variation 46
75841795 h*ng/mL
Geometric Coefficient of Variation 35
151321351 h*ng/mL
Geometric Coefficient of Variation 17
72506970 h*ng/mL
Geometric Coefficient of Variation 42
6228807 h*ng/mL
Geometric Coefficient of Variation 14
16061212 h*ng/mL
Geometric Coefficient of Variation NA
Not evaluable due to inadequate number of participants analyzed
BMS-986207 Area Under the Serum Concentration-time Curve in One Dosing Interval AUC (TAU)
Cycle 3 Day 1
113248878 h*ng/mL
Geometric Coefficient of Variation NA
Not evaluable due to inadequate number of participants analyzed
44114081 h*ng/mL
Geometric Coefficient of Variation 23
124674549 h*ng/mL
Geometric Coefficient of Variation 38
56012897 h*ng/mL
Geometric Coefficient of Variation 46
53257007 h*ng/mL
Geometric Coefficient of Variation 82

SECONDARY outcome

Timeframe: Day 1 of Cycle 1, Cycle 2 and Cycle 3 (Each cycle is of 8 weeks)

Population: All treated participants who have evaluable concentration-time data were included in the analysis. Only participants with evaluable concentration-time data at particular timepoint are considered in the analysis. Participant in Part 1A BMS-986207 Safety Run In did not meet criteria of evaluable concentration-time data hence not included in the analysis.

Blood samples were collected for assessing Ctau.

Outcome measures

Outcome measures
Measure
Part 1A BMS-986207 Safety Run In
n=2 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with total 48 mg of BMS-986207 as 60 minutes intravenous infusion in one cycle (each cycle of 8 weeks).
Part 1A BMS-986207 20 mg
n=3 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 20 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 80 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 240 mg
n=8 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 800 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 1600 mg
n=20 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w) or 2 doses of BMS-986207 administered every 4 weeks (q4w).
Part 2A BMS-986207 800 mg (CRC)
n=4 Participants
Participants with colorectal cancer (CRC) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1B BMS-986207 80 mg + Nivolumab 240 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
Part 1B BMS-986207 240 mg + Nivolumab 240 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
Part 1B BMS-986207 1600 mg + Nivolumab 480 mg
n=18 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Part 1B: BMS-986207 480 mg + Nivolumab 480 mg
n=6 Participants
Participants with CRC or ovarian cancer or hepatocellular carcinoma were administered with 480 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Part 1C BMS-986207 1200 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
n=18 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with Nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and Ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the Nivolumab infusion.
Part 1C BMS-986207 600 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
n=5 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Part 2C BMS-986207 600 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
Participants with first-line non-small cell lung cancer were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
BMS-986207 Observed Serum Concentration at the End of a Dosing Interval (Ctau)
Cycle 1 Day 1
1657 ng/mL
Geometric Coefficient of Variation 24
6526 ng/mL
Geometric Coefficient of Variation 41
20264 ng/mL
Geometric Coefficient of Variation 34
79783 ng/mL
Geometric Coefficient of Variation 18
118571 ng/mL
Geometric Coefficient of Variation 29
51893 ng/mL
Geometric Coefficient of Variation 53
5875 ng/mL
Geometric Coefficient of Variation 31
9560 ng/mL
Geometric Coefficient of Variation 158
66597 ng/mL
Geometric Coefficient of Variation 44
17353 ng/mL
Geometric Coefficient of Variation 56
75172 ng/mL
Geometric Coefficient of Variation 36
26556 ng/mL
Geometric Coefficient of Variation 54
22879 ng/mL
Geometric Coefficient of Variation 61
BMS-986207 Observed Serum Concentration at the End of a Dosing Interval (Ctau)
Cycle 2 Day 1
2790 ng/mL
Geometric Coefficient of Variation NA
Not evaluable due to inadequate number of participants analyzed
18500 ng/mL
Geometric Coefficient of Variation NA
Not evaluable due to inadequate number of participants analyzed
43315 ng/mL
Geometric Coefficient of Variation 45
157016 ng/mL
Geometric Coefficient of Variation 48
383682 ng/mL
Geometric Coefficient of Variation 37
136133 ng/mL
Geometric Coefficient of Variation 54
11449 ng/mL
Geometric Coefficient of Variation 24
34400 ng/mL
Geometric Coefficient of Variation NA
Not evaluable due to inadequate number of participants analyzed
BMS-986207 Observed Serum Concentration at the End of a Dosing Interval (Ctau)
Cycle 3 Day 1
83300 ng/mL
Geometric Coefficient of Variation NA
Not evaluable due to inadequate number of participants analyzed
34396 ng/mL
Geometric Coefficient of Variation 43
149964 ng/mL
Geometric Coefficient of Variation 23
61568 ng/mL
Geometric Coefficient of Variation 53
37051 ng/mL
Geometric Coefficient of Variation 272

SECONDARY outcome

Timeframe: Day 1 of Cycle 1, Cycle 2 and Cycle 3 (Each cycle is of 8 weeks)

Population: All treated participants who have evaluable concentration-time data were included in the analysis. Only participants with evaluable concentration-time data at particular timepoint are considered in the analysis. Participant in Part 1A BMS-986207 Safety Run In did not meet criteria of evaluable concentration-time data hence not included in the analysis.

Blood samples were collected for assessing CLT.

Outcome measures

Outcome measures
Measure
Part 1A BMS-986207 Safety Run In
n=1 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with total 48 mg of BMS-986207 as 60 minutes intravenous infusion in one cycle (each cycle of 8 weeks).
Part 1A BMS-986207 20 mg
n=1 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 20 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 80 mg
n=3 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 240 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 800 mg
n=2 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 1600 mg
n=5 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w) or 2 doses of BMS-986207 administered every 4 weeks (q4w).
Part 2A BMS-986207 800 mg (CRC)
n=3 Participants
Participants with colorectal cancer (CRC) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1B BMS-986207 80 mg + Nivolumab 240 mg
n=1 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
Part 1B BMS-986207 240 mg + Nivolumab 240 mg
n=1 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
Part 1B BMS-986207 1600 mg + Nivolumab 480 mg
n=9 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Part 1B: BMS-986207 480 mg + Nivolumab 480 mg
n=2 Participants
Participants with CRC or ovarian cancer or hepatocellular carcinoma were administered with 480 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Part 1C BMS-986207 1200 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with Nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and Ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the Nivolumab infusion.
Part 1C BMS-986207 600 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
n=2 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Part 2C BMS-986207 600 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
Participants with first-line non-small cell lung cancer were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
BMS-986207 Total Body Clearance (CLT)
Cycle 2 Day 1
0.014 L/h
Geometric Coefficient of Variation NA
Not evaluable due to inadequate number of participants analyzed
0.009 L/h
Geometric Coefficient of Variation NA
Not evaluable due to inadequate number of participants analyzed
0.011 L/h
Geometric Coefficient of Variation 46
0.011 L/h
Geometric Coefficient of Variation 35
0.011 L/h
Geometric Coefficient of Variation 17
0.011 L/h
Geometric Coefficient of Variation 42
0.013 L/h
Geometric Coefficient of Variation 14
0.015 L/h
Geometric Coefficient of Variation NA
Not evaluable due to inadequate number of participants analyzed
BMS-986207 Total Body Clearance (CLT)
Cycle 3 Day 1
0.014 L/h
Geometric Coefficient of Variation NA
Not evaluable due to inadequate number of participants analyzed.
0.011 L/h
Geometric Coefficient of Variation 23
0.007 L/h
Geometric Coefficient of Variation 13
0.011 L/h
Geometric Coefficient of Variation 46
0.011 L/h
Geometric Coefficient of Variation 82

SECONDARY outcome

Timeframe: Day 1 of Cycle 1, Cycle 2 and Cycle 3 (Each cycle is of 8 weeks)

Population: All treated participants who have evaluable concentration-time data were included in the analysis. Only participants with evaluable concentration-time data at particular timepoint are considered in the analysis. Participant in Part 1A BMS-986207 Safety Run In did not meet criteria of evaluable concentration-time data hence not included in the analysis.

Blood samples were collected for assessing Css-avg.

Outcome measures

Outcome measures
Measure
Part 1A BMS-986207 Safety Run In
n=1 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with total 48 mg of BMS-986207 as 60 minutes intravenous infusion in one cycle (each cycle of 8 weeks).
Part 1A BMS-986207 20 mg
n=1 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 20 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 80 mg
n=3 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 240 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 800 mg
n=2 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 1600 mg
n=5 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w) or 2 doses of BMS-986207 administered every 4 weeks (q4w).
Part 2A BMS-986207 800 mg (CRC)
n=3 Participants
Participants with colorectal cancer (CRC) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1B BMS-986207 80 mg + Nivolumab 240 mg
n=1 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
Part 1B BMS-986207 240 mg + Nivolumab 240 mg
n=1 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
Part 1B BMS-986207 1600 mg + Nivolumab 480 mg
n=9 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Part 1B: BMS-986207 480 mg + Nivolumab 480 mg
n=2 Participants
Participants with CRC or ovarian cancer or hepatocellular carcinoma were administered with 480 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Part 1C BMS-986207 1200 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with Nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and Ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the Nivolumab infusion.
Part 1C BMS-986207 600 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
n=2 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Part 2C BMS-986207 600 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
Participants with first-line non-small cell lung cancer were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
BMS-986207 Average Concentration Over a Dosing Interval (Css-avg)
Cycle 2 Day 1
4281 ng/mL
Geometric Coefficient of Variation NA
Not evaluable due to inadequate number of participants analyzed
25746 ng/mL
Geometric Coefficient of Variation NA
Not evaluable due to inadequate number of participants analyzed
64581 ng/mL
Geometric Coefficient of Variation 46
225882 ng/mL
Geometric Coefficient of Variation 35
451954 ng/mL
Geometric Coefficient of Variation 17
209969 ng/mL
Geometric Coefficient of Variation 46
18650 ng/mL
Geometric Coefficient of Variation 15
48112 ng/mL
Geometric Coefficient of Variation NA
Not evaluable due to inadequate number of participants analyzed
BMS-986207 Average Concentration Over a Dosing Interval (Css-avg)
Cycle 3 Day 1
168655 ng/mL
Geometric Coefficient of Variation NA
Not evaluable due to inadequate number of participants analyzed
67521 ng/mL
Geometric Coefficient of Variation 23
247899 ng/mL
Geometric Coefficient of Variation 37
113134 ng/mL
Geometric Coefficient of Variation 46
103591 ng/mL
Geometric Coefficient of Variation 78

SECONDARY outcome

Timeframe: Day 1 of Cycle 1, Cycle 2 and Cycle 3 (Each cycle is of 8 weeks)

Population: All treated participants who have evaluable concentration-time data were included in the analysis. Only participants with evaluable concentration-time data at particular timepoint are considered in the analysis. Participant in Part 1A BMS-986207 Safety Run In did not meet criteria of evaluable concentration-time data hence not included in the analysis.

Blood samples were collected for assessing AI\_TAU.

Outcome measures

Outcome measures
Measure
Part 1A BMS-986207 Safety Run In
n=1 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with total 48 mg of BMS-986207 as 60 minutes intravenous infusion in one cycle (each cycle of 8 weeks).
Part 1A BMS-986207 20 mg
n=1 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 20 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 80 mg
n=3 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 240 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 800 mg
n=2 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 1600 mg
n=5 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w) or 2 doses of BMS-986207 administered every 4 weeks (q4w).
Part 2A BMS-986207 800 mg (CRC)
n=3 Participants
Participants with colorectal cancer (CRC) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1B BMS-986207 80 mg + Nivolumab 240 mg
n=1 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
Part 1B BMS-986207 240 mg + Nivolumab 240 mg
n=1 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
Part 1B BMS-986207 1600 mg + Nivolumab 480 mg
n=9 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Part 1B: BMS-986207 480 mg + Nivolumab 480 mg
n=2 Participants
Participants with CRC or ovarian cancer or hepatocellular carcinoma were administered with 480 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Part 1C BMS-986207 1200 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with Nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and Ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the Nivolumab infusion.
Part 1C BMS-986207 600 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
n=2 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Part 2C BMS-986207 600 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
Participants with first-line non-small cell lung cancer were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
BMS-986207 Ratio of an Exposure Measure at Steady State to That After the First Dose (AI_TAU)
Cycle 2 Day 1
1.42 Ratio
Geometric Coefficient of Variation NA
Not evaluable due to inadequate number of participants analyzed
2.00 Ratio
1.94 Ratio
Geometric Coefficient of Variation 17
1.91 Ratio
Geometric Coefficient of Variation 29
2.04 Ratio
Geometric Coefficient of Variation 2
1.97 Ratio
Geometric Coefficient of Variation 11
1.35 Ratio
Geometric Coefficient of Variation 57
1.93 Ratio
Geometric Coefficient of Variation NA
Not evaluable due to inadequate number of participants analyzed
BMS-986207 Ratio of an Exposure Measure at Steady State to That After the First Dose (AI_TAU)
Cycle 3 Day 1
1.40 Ratio
Geometric Coefficient of Variation NA
Not evaluable due to inadequate number of participants analyzed
1.47 Ratio
Geometric Coefficient of Variation 11
1.19 Ratio
Geometric Coefficient of Variation 34
1.46 Ratio
Geometric Coefficient of Variation 8
1.40 Ratio
Geometric Coefficient of Variation 102

SECONDARY outcome

Timeframe: Day 1 of Cycle 1, Cycle 2 and Cycle 3 (Each cycle is of 8 weeks)

Population: All treated participants who have evaluable concentration-time data were included in the analysis. Only participants with evaluable concentration-time data at particular timepoint are considered in the analysis. Participant in Part 1A BMS-986207 Safety Run In did not meet criteria of evaluable concentration-time data hence not included in the analysis.

Blood samples were collected for assessing T-HALFeff. Exposure measure includes AUC\[TAU\].

Outcome measures

Outcome measures
Measure
Part 1A BMS-986207 Safety Run In
n=1 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with total 48 mg of BMS-986207 as 60 minutes intravenous infusion in one cycle (each cycle of 8 weeks).
Part 1A BMS-986207 20 mg
n=1 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 20 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 80 mg
n=3 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 240 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 800 mg
n=2 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 1600 mg
n=5 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w) or 2 doses of BMS-986207 administered every 4 weeks (q4w).
Part 2A BMS-986207 800 mg (CRC)
n=2 Participants
Participants with colorectal cancer (CRC) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1B BMS-986207 80 mg + Nivolumab 240 mg
n=1 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
Part 1B BMS-986207 240 mg + Nivolumab 240 mg
n=1 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
Part 1B BMS-986207 1600 mg + Nivolumab 480 mg
n=9 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Part 1B: BMS-986207 480 mg + Nivolumab 480 mg
n=1 Participants
Participants with CRC or ovarian cancer or hepatocellular carcinoma were administered with 480 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Part 1C BMS-986207 1200 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with Nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and Ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the Nivolumab infusion.
Part 1C BMS-986207 600 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
n=1 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Part 2C BMS-986207 600 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
Participants with first-line non-small cell lung cancer were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
BMS-986207 Effective Elimination Half-life That Explains the Degree of Accumulation Observed for a Specific Exposure Measure (T-HALFeff)
Cycle 3 Day 1
372 hours
Geometric Coefficient of Variation NA
Not evaluable due to inadequate number of participants analyzed
390 hours
Geometric Coefficient of Variation 32
317 hours
Geometric Coefficient of Variation NA
Not evaluable due to inadequate number of participants analyzed
294 hours
Geometric Coefficient of Variation 16
722 hours
Geometric Coefficient of Variation NA
Not evaluable due to inadequate number of participants analyzed
BMS-986207 Effective Elimination Half-life That Explains the Degree of Accumulation Observed for a Specific Exposure Measure (T-HALFeff)
Cycle 2 Day 1
189 hours
Geometric Coefficient of Variation NA
Not evaluable due to inadequate number of participants analyzed
334 hours
Geometric Coefficient of Variation NA
Not evaluable due to inadequate number of participants analyzed
319 hours
Geometric Coefficient of Variation 26
306 hours
Geometric Coefficient of Variation 43
344 hours
Geometric Coefficient of Variation 3
338 hours
Geometric Coefficient of Variation 14
293 hours
Geometric Coefficient of Variation 11
317 hours
Geometric Coefficient of Variation NA
Not evaluable due to inadequate number of participants analyzed

SECONDARY outcome

Timeframe: From first dose (Day 1) till 100 days after last dose (Up to approximately 27 months)

Population: All Treated Participants with Baseline and at Least One Post-baseline Evaluable ADA Assessment were included in the analysis.

Participants who were treated with BMS-986207 and at least one post-baseline evaluable ADA assessment were considered in the analysis

Outcome measures

Outcome measures
Measure
Part 1A BMS-986207 Safety Run In
n=1 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with total 48 mg of BMS-986207 as 60 minutes intravenous infusion in one cycle (each cycle of 8 weeks).
Part 1A BMS-986207 20 mg
n=2 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 20 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 80 mg
n=3 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 240 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 800 mg
n=8 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 1600 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w) or 2 doses of BMS-986207 administered every 4 weeks (q4w).
Part 2A BMS-986207 800 mg (CRC)
n=20 Participants
Participants with colorectal cancer (CRC) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1B BMS-986207 80 mg + Nivolumab 240 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
Part 1B BMS-986207 240 mg + Nivolumab 240 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
Part 1B BMS-986207 1600 mg + Nivolumab 480 mg
n=4 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Part 1B: BMS-986207 480 mg + Nivolumab 480 mg
n=14 Participants
Participants with CRC or ovarian cancer or hepatocellular carcinoma were administered with 480 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Part 1C BMS-986207 1200 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
n=2 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with Nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and Ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the Nivolumab infusion.
Part 1C BMS-986207 600 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
n=5 Participants
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Part 2C BMS-986207 600 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
n=3 Participants
Participants with first-line non-small cell lung cancer were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Number of Participants With Positive Anti-BMS-986207-Antibodies Results
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants

Adverse Events

Part 1A BMS-986207 Safety Run In

Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths

Part 1A BMS-986207 20 mg

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Part 1A BMS-986207 80 mg

Serious events: 3 serious events
Other events: 3 other events
Deaths: 3 deaths

Part 1A BMS-986207 240 mg

Serious events: 3 serious events
Other events: 4 other events
Deaths: 2 deaths

Part 1A BMS-986207 800 mg

Serious events: 5 serious events
Other events: 8 other events
Deaths: 5 deaths

Part 1A BMS-986207 1600 mg

Serious events: 1 serious events
Other events: 4 other events
Deaths: 2 deaths

Part 2A BMS-986207 800 mg (CRC)

Serious events: 11 serious events
Other events: 20 other events
Deaths: 15 deaths

Part 1B BMS-986207 80 mg + Nivolumab 240 mg

Serious events: 3 serious events
Other events: 3 other events
Deaths: 2 deaths

Part 1B BMS-986207 240 mg + Nivolumab 240 mg

Serious events: 2 serious events
Other events: 4 other events
Deaths: 4 deaths

Part 1B BMS-986207 1600 mg + Nivolumab 480 mg

Serious events: 1 serious events
Other events: 4 other events
Deaths: 4 deaths

Part 1B: BMS-986207 480 mg + Nivolumab 480 mg

Serious events: 6 serious events
Other events: 18 other events
Deaths: 7 deaths

Part 1C BMS-986207 1200 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg

Serious events: 4 serious events
Other events: 6 other events
Deaths: 3 deaths

Part 1C BMS-986207 600 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg

Serious events: 11 serious events
Other events: 18 other events
Deaths: 13 deaths

Part 2C BMS-986207 600 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg

Serious events: 5 serious events
Other events: 5 other events
Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure
Part 1A BMS-986207 Safety Run In
n=1 participants at risk
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with total 48 mg of BMS-986207 as 60 minutes intravenous infusion in one cycle (each cycle of 8 weeks).
Part 1A BMS-986207 20 mg
n=2 participants at risk
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 20 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 80 mg
n=3 participants at risk
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 240 mg
n=4 participants at risk
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 800 mg
n=8 participants at risk
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 1600 mg
n=4 participants at risk
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w) or 2 doses of BMS-986207 administered every 4 weeks (q4w).
Part 2A BMS-986207 800 mg (CRC)
n=20 participants at risk
Participants with colorectal cancer (CRC) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1B BMS-986207 80 mg + Nivolumab 240 mg
n=4 participants at risk
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
Part 1B BMS-986207 240 mg + Nivolumab 240 mg
n=4 participants at risk
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
Part 1B BMS-986207 1600 mg + Nivolumab 480 mg
n=4 participants at risk
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Part 1B: BMS-986207 480 mg + Nivolumab 480 mg
n=18 participants at risk
Participants with CRC or ovarian cancer or hepatocellular carcinoma were administered with 480 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Part 1C BMS-986207 1200 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
n=6 participants at risk
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with Nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and Ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the Nivolumab infusion.
Part 1C BMS-986207 600 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
n=18 participants at risk
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Part 2C BMS-986207 600 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
n=5 participants at risk
Participants with first-line non-small cell lung cancer were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Cardiac disorders
Atrial fibrillation
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Cardiac disorders
Atrioventricular block complete
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Cardiac disorders
Cardiac tamponade
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
20.0%
1/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Cardiac disorders
Myocarditis
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Endocrine disorders
Adrenal insufficiency
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
11.1%
2/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Endocrine disorders
Inappropriate antidiuretic hormone secretion
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
16.7%
1/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Eye disorders
Exophthalmos
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Gastrointestinal disorders
Abdominal pain
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
16.7%
1/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Gastrointestinal disorders
Abdominal pain lower
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
16.7%
1/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Gastrointestinal disorders
Enterocolitis
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
16.7%
1/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Gastrointestinal disorders
Gastrointestinal haemorrhage
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Gastrointestinal disorders
Intestinal obstruction
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.0%
1/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Gastrointestinal disorders
Rectal haemorrhage
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Gastrointestinal disorders
Small intestinal obstruction
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
General disorders
Pyrexia
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
10.0%
2/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Hepatobiliary disorders
Bile duct stenosis
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Hepatobiliary disorders
Hyperbilirubinaemia
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.0%
1/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Hepatobiliary disorders
Jaundice cholestatic
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.0%
1/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Immune system disorders
Allergic oedema
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Immune system disorders
Hypersensitivity
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Infections and infestations
Bacteraemia
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.0%
1/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Infections and infestations
Cellulitis
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Infections and infestations
Encephalitis
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
16.7%
1/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Infections and infestations
Pneumococcal sepsis
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Infections and infestations
Pneumonia
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
20.0%
1/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Infections and infestations
Pneumonia aspiration
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
33.3%
1/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Infections and infestations
Septic shock
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
20.0%
1/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Infections and infestations
Stoma site cellulitis
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Infections and infestations
Urinary tract infection
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Nervous system disorders
Epilepsy
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Infections and infestations
Vascular device infection
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Infections and infestations
Wound infection
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
16.7%
1/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Injury, poisoning and procedural complications
Fall
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Investigations
Aspartate aminotransferase increased
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Investigations
Blood alkaline phosphatase increased
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.0%
1/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Investigations
Blood bilirubin increased
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.0%
1/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Metabolism and nutrition disorders
Hypoglycaemia
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Metabolism and nutrition disorders
Hyponatraemia
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
20.0%
1/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Musculoskeletal and connective tissue disorders
Arthralgia
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Musculoskeletal and connective tissue disorders
Muscular weakness
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain cancer metastatic
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenocarcinoma
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.0%
1/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer metastatic
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.0%
1/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
100.0%
1/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
66.7%
2/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
37.5%
3/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
5/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
50.0%
2/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
33.3%
2/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
20.0%
1/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
10.0%
2/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.0%
1/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Nervous system disorders
Spinal cord compression
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Nervous system disorders
Syncope
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Nervous system disorders
Vocal cord paralysis
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Respiratory, thoracic and mediastinal disorders
Pneumonitis
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
40.0%
2/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Skin and subcutaneous tissue disorders
Dermatitis bullous
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
16.7%
1/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Vascular disorders
Embolism
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.0%
1/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.

Other adverse events

Other adverse events
Measure
Part 1A BMS-986207 Safety Run In
n=1 participants at risk
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with total 48 mg of BMS-986207 as 60 minutes intravenous infusion in one cycle (each cycle of 8 weeks).
Part 1A BMS-986207 20 mg
n=2 participants at risk
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 20 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 80 mg
n=3 participants at risk
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 240 mg
n=4 participants at risk
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 800 mg
n=8 participants at risk
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1A BMS-986207 1600 mg
n=4 participants at risk
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w) or 2 doses of BMS-986207 administered every 4 weeks (q4w).
Part 2A BMS-986207 800 mg (CRC)
n=20 participants at risk
Participants with colorectal cancer (CRC) were administered with 800 milligram of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every 2 weeks (q2w).
Part 1B BMS-986207 80 mg + Nivolumab 240 mg
n=4 participants at risk
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 80 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
Part 1B BMS-986207 240 mg + Nivolumab 240 mg
n=4 participants at risk
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 240 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered every q2w. Participants were also administered with Nivolumab 240 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q2w.
Part 1B BMS-986207 1600 mg + Nivolumab 480 mg
n=4 participants at risk
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Part 1B: BMS-986207 480 mg + Nivolumab 480 mg
n=18 participants at risk
Participants with CRC or ovarian cancer or hepatocellular carcinoma were administered with 480 mg of BMS-986207 as 60 minutes intravenous infusion for up to maximum of 6 cycles (each cycle is of 8 weeks). Each cycle comprise 4 doses of BMS-986207 administered q4w. Participants were also administered with Nivolumab 480 mg as 60 minutes intravenous infusion for up to maximum of 6 cycles and each cycle comprise 4 doses of Nivolumab administered q4w.
Part 1C BMS-986207 1200 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
n=6 participants at risk
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 1600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with Nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and Ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the Nivolumab infusion.
Part 1C BMS-986207 600 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
n=18 participants at risk
Participants with advanced solid tumors (metastatic, recurrent and/or unresectable) were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Part 2C BMS-986207 600 mg + Nivolumab 360 mg + Ipilimumab 1 mg/kg
n=5 participants at risk
Participants with first-line non-small cell lung cancer were administered with 600 mg of BMS-986207 every 3 weeks (q3w) as 60 minutes intravenous infusion for up to PD, unacceptable toxicity, or other protocol defined reasons or maximum of 2 years. Participants were also administered with nivolumab 360 mg as 60 minutes intravenous infusion every 3 weeks (q3w) and ipilimumab 1 mg/kg as intravenous infusion every 6 weeks at least 30 minutes after completion of the nivolumab infusion.
Eye disorders
Periorbital swelling
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Eye disorders
Vision blurred
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
50.0%
2/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Blood and lymphatic system disorders
Anaemia
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
50.0%
1/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
33.3%
1/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
2/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
50.0%
2/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
15.0%
3/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
50.0%
2/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
50.0%
2/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
16.7%
3/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
50.0%
3/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
16.7%
3/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
80.0%
4/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Blood and lymphatic system disorders
Iron deficiency anaemia
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Blood and lymphatic system disorders
Leukocytosis
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Blood and lymphatic system disorders
Leukopenia
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Blood and lymphatic system disorders
Neutropenia
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Blood and lymphatic system disorders
Pernicious anaemia
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Blood and lymphatic system disorders
Splenomegaly
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Blood and lymphatic system disorders
Thrombocytopenia
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
16.7%
1/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Cardiac disorders
Atrial fibrillation
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Cardiac disorders
Bradycardia
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Cardiac disorders
Myocarditis
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Cardiac disorders
Sinus tachycardia
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
10.0%
2/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Cardiac disorders
Tachycardia
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
20.0%
1/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Ear and labyrinth disorders
Ear pruritus
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Endocrine disorders
Adrenal insufficiency
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Endocrine disorders
Hyperthyroidism
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
16.7%
1/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Endocrine disorders
Hypothyroidism
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Eye disorders
Conjunctival haemorrhage
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Eye disorders
Ocular hyperaemia
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Eye disorders
Periorbital oedema
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Eye disorders
Visual impairment
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Gastrointestinal disorders
Abdominal distension
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.0%
1/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Infections and infestations
COVID-19 pneumonia
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Gastrointestinal disorders
Abdominal pain
100.0%
1/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
2/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
5/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
33.3%
2/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Gastrointestinal disorders
Abdominal pain upper
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.0%
1/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
20.0%
1/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Gastrointestinal disorders
Aptyalism
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Gastrointestinal disorders
Ascites
100.0%
1/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Gastrointestinal disorders
Constipation
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
2/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
20.0%
4/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
50.0%
2/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
11.1%
2/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
40.0%
2/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Gastrointestinal disorders
Diarrhoea
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
50.0%
1/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
2/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
20.0%
4/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
11.1%
2/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Gastrointestinal disorders
Dry mouth
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Gastrointestinal disorders
Dyspepsia
100.0%
1/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.0%
1/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Gastrointestinal disorders
Dysphagia
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Gastrointestinal disorders
Flatulence
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Gastrointestinal disorders
Frequent bowel movements
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Gastrointestinal disorders
Gastrointestinal pain
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Gastrointestinal disorders
Gastrooesophageal reflux disease
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.0%
1/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
16.7%
1/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Gastrointestinal disorders
Nausea
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
33.3%
1/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
50.0%
2/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
50.0%
2/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
15.0%
3/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
22.2%
4/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
16.7%
1/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
16.7%
3/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
40.0%
2/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Gastrointestinal disorders
Oesophageal rupture
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Gastrointestinal disorders
Oesophagitis
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Gastrointestinal disorders
Oesophagomediastinal fistula
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
33.3%
1/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Gastrointestinal disorders
Oral pain
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Gastrointestinal disorders
Proctalgia
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Gastrointestinal disorders
Rectal haemorrhage
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Gastrointestinal disorders
Salivary duct inflammation
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
16.7%
1/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Gastrointestinal disorders
Stomatitis
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
20.0%
1/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Gastrointestinal disorders
Vomiting
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
50.0%
2/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
37.5%
3/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
15.0%
3/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
11.1%
2/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
11.1%
2/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
20.0%
1/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
General disorders
Asthenia
100.0%
1/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
General disorders
Chills
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
2/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.0%
1/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
11.1%
2/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
General disorders
Fatigue
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
50.0%
1/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
50.0%
2/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
62.5%
5/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
20.0%
4/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
50.0%
2/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
27.8%
5/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
27.8%
5/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
60.0%
3/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
General disorders
Gait disturbance
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
16.7%
1/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
General disorders
Influenza like illness
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
General disorders
Localised oedema
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
General disorders
Malaise
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
33.3%
1/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
General disorders
Multiple organ dysfunction syndrome
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
General disorders
Nodule
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
General disorders
Non-cardiac chest pain
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
33.3%
1/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.0%
1/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
General disorders
Oedema peripheral
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
33.3%
1/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
37.5%
3/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
10.0%
2/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
11.1%
2/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
16.7%
1/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
General disorders
Pain
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.0%
1/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
16.7%
1/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
General disorders
Peripheral swelling
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
General disorders
Pyrexia
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
50.0%
1/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
10.0%
2/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
50.0%
2/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
50.0%
2/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
11.1%
2/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
38.9%
7/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
20.0%
1/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
General disorders
Swelling face
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
16.7%
1/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
General disorders
Vessel puncture site erythema
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
General disorders
Xerosis
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
40.0%
2/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Hepatobiliary disorders
Hepatic function abnormal
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.0%
1/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Hepatobiliary disorders
Portal vein thrombosis
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Infections and infestations
Bronchitis
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
33.3%
1/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
20.0%
1/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Infections and infestations
COVID-19
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
20.0%
1/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Infections and infestations
Cellulitis
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
16.7%
1/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Infections and infestations
Cryptosporidiosis infection
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Infections and infestations
Encephalitis
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
16.7%
1/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Infections and infestations
Eye infection
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Infections and infestations
Herpes zoster
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.0%
1/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Metabolism and nutrition disorders
Hyperuricaemia
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
11.1%
2/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Infections and infestations
Localised infection
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Infections and infestations
Lower respiratory tract infection
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Infections and infestations
Nasopharyngitis
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
20.0%
1/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Infections and infestations
Oral candidiasis
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
33.3%
1/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
16.7%
1/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Infections and infestations
Paronychia
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Infections and infestations
Pharyngitis
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Infections and infestations
Pneumonia
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
20.0%
1/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Infections and infestations
Pneumonia bacterial
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
20.0%
1/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Infections and infestations
Skin infection
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
16.7%
1/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Infections and infestations
Stoma site abscess
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Infections and infestations
Stoma site cellulitis
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Infections and infestations
Stoma site infection
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Infections and infestations
Upper respiratory tract infection
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Infections and infestations
Urinary tract infection
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.0%
1/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
11.1%
2/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Infections and infestations
Wound infection
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Injury, poisoning and procedural complications
Eye contusion
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Injury, poisoning and procedural complications
Fall
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
16.7%
1/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Injury, poisoning and procedural complications
Hand fracture
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Injury, poisoning and procedural complications
Infusion related reaction
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.0%
1/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
11.1%
2/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
20.0%
1/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Injury, poisoning and procedural complications
Procedural pain
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
50.0%
1/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Injury, poisoning and procedural complications
Radiation skin injury
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Injury, poisoning and procedural complications
Tooth fracture
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Investigations
Adjusted calcium increased
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
20.0%
1/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Investigations
Alanine aminotransferase increased
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
2/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
16.7%
1/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
22.2%
4/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
20.0%
1/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Investigations
Ammonia increased
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
11.1%
2/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Investigations
Amylase increased
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
33.3%
2/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
20.0%
1/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Investigations
Aspartate aminotransferase decreased
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Investigations
Aspartate aminotransferase increased
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
37.5%
3/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
50.0%
2/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
16.7%
1/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
16.7%
3/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
40.0%
2/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Investigations
Blood albumin decreased
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
20.0%
1/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Investigations
Blood alkaline phosphatase increased
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
33.3%
1/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
75.0%
3/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Metabolism and nutrition disorders
Hypoalbuminaemia
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
33.3%
1/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.0%
1/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
11.1%
2/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Investigations
Blood bilirubin increased
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
10.0%
2/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
20.0%
1/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Investigations
Blood calcium increased
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
20.0%
1/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Investigations
Blood cholesterol increased
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
20.0%
1/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Investigations
Blood creatinine increased
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
16.7%
1/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
16.7%
3/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
40.0%
2/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Investigations
Blood glucose increased
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
20.0%
1/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Nervous system disorders
Sensory disturbance
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
20.0%
1/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Investigations
Blood lactate dehydrogenase increased
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
11.1%
2/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Investigations
Blood magnesium decreased
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
20.0%
1/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Investigations
Blood potassium decreased
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
33.3%
1/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
20.0%
1/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Investigations
Blood sodium decreased
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Investigations
Blood testosterone decreased
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Investigations
Blood thyroid stimulating hormone decreased
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
20.0%
1/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Investigations
Blood thyroid stimulating hormone increased
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
33.3%
1/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
40.0%
2/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Investigations
Blood urea increased
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Investigations
Blood uric acid increased
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Investigations
Drug level increased
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Investigations
Gamma-glutamyltransferase increased
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
33.3%
1/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
16.7%
1/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Investigations
International normalised ratio increased
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Investigations
Lipase decreased
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Investigations
Lipase increased
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
50.0%
1/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.0%
1/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
11.1%
2/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
16.7%
1/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
40.0%
2/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Investigations
Lymphocyte count decreased
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.0%
1/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
50.0%
2/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
11.1%
2/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Investigations
Lymphocyte count increased
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Investigations
Neutrophil count decreased
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
16.7%
1/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Investigations
Neutrophil count increased
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Investigations
Platelet count decreased
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
16.7%
1/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Investigations
Protein total decreased
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Investigations
Troponin increased
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
11.1%
2/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Investigations
Weight decreased
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
50.0%
2/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
2/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
5/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
40.0%
2/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Investigations
Weight increased
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.0%
1/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Investigations
White blood cell count decreased
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Metabolism and nutrition disorders
Acidosis
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Metabolism and nutrition disorders
Decreased appetite
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
50.0%
2/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
37.5%
3/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
20.0%
4/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
22.2%
4/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
20.0%
1/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Metabolism and nutrition disorders
Dehydration
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
50.0%
2/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
10.0%
2/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
11.1%
2/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
16.7%
1/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Metabolism and nutrition disorders
Glucose tolerance impaired
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Metabolism and nutrition disorders
Hypercalcaemia
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
33.3%
1/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
11.1%
2/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Metabolism and nutrition disorders
Hyperglycaemia
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
10.0%
2/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
11.1%
2/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Metabolism and nutrition disorders
Hyperkalaemia
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
50.0%
1/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
10.0%
2/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
11.1%
2/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Metabolism and nutrition disorders
Hyperphosphataemia
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.0%
1/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Metabolism and nutrition disorders
Hypocalcaemia
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Metabolism and nutrition disorders
Hypoglycaemia
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Metabolism and nutrition disorders
Hypokalaemia
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
33.3%
1/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
10.0%
2/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
16.7%
3/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Metabolism and nutrition disorders
Hypomagnesaemia
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
20.0%
1/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Metabolism and nutrition disorders
Hyponatraemia
100.0%
1/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
50.0%
2/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.0%
1/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
33.3%
2/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
33.3%
6/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
60.0%
3/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Metabolism and nutrition disorders
Hypophosphataemia
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
33.3%
1/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Metabolism and nutrition disorders
Malnutrition
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Musculoskeletal and connective tissue disorders
Arthralgia
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
50.0%
1/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
2/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.0%
1/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Musculoskeletal and connective tissue disorders
Arthritis
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.0%
1/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
16.7%
3/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
16.7%
1/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Musculoskeletal and connective tissue disorders
Bone pain
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
33.3%
1/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Musculoskeletal and connective tissue disorders
Exostosis
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
50.0%
1/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Musculoskeletal and connective tissue disorders
Flank pain
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
16.7%
1/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Musculoskeletal and connective tissue disorders
Greater trochanteric pain syndrome
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Musculoskeletal and connective tissue disorders
Joint swelling
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
16.7%
1/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Musculoskeletal and connective tissue disorders
Muscular weakness
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Musculoskeletal and connective tissue disorders
Myalgia
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
50.0%
1/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
2/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.0%
1/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
40.0%
2/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Musculoskeletal and connective tissue disorders
Neck pain
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Musculoskeletal and connective tissue disorders
Pain in extremity
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.0%
1/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
16.7%
1/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
20.0%
1/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Musculoskeletal and connective tissue disorders
Spinal pain
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
33.3%
1/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer metastatic
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal papilloma
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Peritumoural oedema
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Nervous system disorders
Aphasia
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
16.7%
1/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Nervous system disorders
Ataxia
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Nervous system disorders
Brain oedema
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Nervous system disorders
Disturbance in attention
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Nervous system disorders
Dizziness
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.0%
1/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
50.0%
2/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
20.0%
1/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Nervous system disorders
Drooling
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Nervous system disorders
Headache
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
11.1%
2/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
16.7%
1/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
20.0%
1/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Nervous system disorders
Hemiparesis
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Nervous system disorders
Lethargy
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Nervous system disorders
Neuropathy peripheral
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
11.1%
2/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Nervous system disorders
Paraesthesia
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Nervous system disorders
Parkinsonism
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
20.0%
1/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Nervous system disorders
Peripheral sensory neuropathy
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
20.0%
1/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Nervous system disorders
Somnolence
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Renal and urinary disorders
Pollakiuria
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
10.0%
2/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Nervous system disorders
Taste disorder
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Nervous system disorders
Tremor
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
20.0%
1/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Nervous system disorders
Ulnar nerve palsy
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Nervous system disorders
Vocal cord paralysis
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Psychiatric disorders
Affective disorder
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
20.0%
1/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Psychiatric disorders
Anxiety
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.0%
1/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Psychiatric disorders
Confusional state
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
11.1%
2/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
16.7%
1/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Psychiatric disorders
Delirium
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Psychiatric disorders
Depression
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
20.0%
1/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Psychiatric disorders
Hallucination
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Psychiatric disorders
Insomnia
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
2/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.0%
1/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
16.7%
1/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
20.0%
1/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Renal and urinary disorders
Acute kidney injury
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Renal and urinary disorders
Dysuria
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
15.0%
3/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Renal and urinary disorders
Proteinuria
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Skin and subcutaneous tissue disorders
Purpura
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Renal and urinary disorders
Urinary incontinence
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Renal and urinary disorders
Urogenital fistula
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Respiratory, thoracic and mediastinal disorders
Cough
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
37.5%
3/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
20.0%
4/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
50.0%
2/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
16.7%
3/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
11.1%
2/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
40.0%
2/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
50.0%
1/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
33.3%
1/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
37.5%
3/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
15.0%
3/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
20.0%
1/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Respiratory, thoracic and mediastinal disorders
Epistaxis
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Respiratory, thoracic and mediastinal disorders
Haemoptysis
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
10.0%
2/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
20.0%
1/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Respiratory, thoracic and mediastinal disorders
Hiccups
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Respiratory, thoracic and mediastinal disorders
Hypoxia
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
33.3%
1/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.0%
1/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Respiratory, thoracic and mediastinal disorders
Nasal congestion
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
10.0%
2/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
33.3%
1/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.0%
1/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
11.1%
2/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
16.7%
1/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
33.3%
1/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.0%
1/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
11.1%
2/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Respiratory, thoracic and mediastinal disorders
Pneumonitis
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
16.7%
1/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
16.7%
3/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
40.0%
2/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Respiratory, thoracic and mediastinal disorders
Pneumothorax
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Respiratory, thoracic and mediastinal disorders
Productive cough
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.0%
1/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Respiratory, thoracic and mediastinal disorders
Respiratory failure
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
20.0%
1/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Respiratory, thoracic and mediastinal disorders
Sneezing
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Respiratory, thoracic and mediastinal disorders
Stridor
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Respiratory, thoracic and mediastinal disorders
Throat irritation
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Respiratory, thoracic and mediastinal disorders
Tracheal fistula
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
33.3%
1/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Respiratory, thoracic and mediastinal disorders
Wheezing
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
33.3%
1/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Skin and subcutaneous tissue disorders
Alopecia
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Skin and subcutaneous tissue disorders
Dermatitis acneiform
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
16.7%
1/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Skin and subcutaneous tissue disorders
Dermatitis allergic
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
11.1%
2/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Skin and subcutaneous tissue disorders
Dermatitis bullous
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
16.7%
1/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Skin and subcutaneous tissue disorders
Dermatitis contact
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Skin and subcutaneous tissue disorders
Dry skin
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.0%
1/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Skin and subcutaneous tissue disorders
Erythema
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
16.7%
1/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Skin and subcutaneous tissue disorders
Hyperkeratosis
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Skin and subcutaneous tissue disorders
Night sweats
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Skin and subcutaneous tissue disorders
Pain of skin
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Skin and subcutaneous tissue disorders
Pruritus
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
10.0%
2/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
11.1%
2/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
16.7%
1/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
11.1%
2/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
40.0%
2/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Skin and subcutaneous tissue disorders
Rash
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
50.0%
1/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.0%
1/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
16.7%
1/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
11.1%
2/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
40.0%
2/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Skin and subcutaneous tissue disorders
Rash macular
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
16.7%
1/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Skin and subcutaneous tissue disorders
Rash maculo-papular
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
16.7%
1/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Skin and subcutaneous tissue disorders
Rash papular
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Skin and subcutaneous tissue disorders
Skin lesion
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
33.3%
1/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Vascular disorders
Embolism
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Vascular disorders
Hypertension
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
12.5%
1/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
15.0%
3/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
44.4%
8/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Vascular disorders
Hypotension
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
5.6%
1/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
20.0%
1/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
Vascular disorders
Vasculitis
0.00%
0/1 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/2 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/3 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/8 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/20 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
25.0%
1/4 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/6 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/18 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.
0.00%
0/5 • All-cause mortality was collected from randomization till death due to any cause (Up to approximately 85 months). Serious adverse events and non serious adverse events were collected from from first dose (Day 1) until 100 days after last dose (Up to approximately 27 months)
All Cause Mortality , Serious and Others (Non-Serious) Adverse events were collected for All Treated Participants.

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please email

Results disclosure agreements

  • Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication
  • Publication restrictions are in place

Restriction type: OTHER