Trial Outcomes & Findings for A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer (NCT NCT05388669)
NCT ID: NCT05388669
Last Updated: 2026-05-08
Results Overview
Ctrough was the observed serum concentration of Amivantamab at steady state immediately prior to the next drug administration.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
418 participants
Primary outcome timeframe
Pre-dose on Cycle 4 Day 1 (each cycle of 28 days)
Results posted on
2026-05-08
Participant Flow
The results are currently reported for primary analysis till clinical cut-off date 03-Jan-2024. Upon completion of the open-label follow-up phase, participants were permitted to enter the long-term extension (LTE) phase. The LTE phase is ongoing and results will be published after the completion of the study.
Participant milestones
| Measure |
Arm A: Lazertinib With Amivantamab SC-CF
Participants were administered lazertinib 240 milligrams (mg) tablet orally once daily from Cycle 1 Day 1 until Cycle 15, with each cycle consisting of 28 days. Participants then received amivantamab subcutaneous injection with at dose 1600 mg (if body weight \[BW\] is less than \[\<\] 80 kilograms \[kg\]) or 2240 mg (if BW is greater than or equal to \[\>=\] 80 kg) co-formulated (SC-CF) with recombinant human hyaluronidase PH20 (rHuPH20) 160 milligrams per milliliter (mg/mL) through manual injection on Cycle 1 Days 1, 8, 15, and 22, and on Days 1 and 15 of each subsequent cycle, starting from Cycle 2. After the completion of primary analysis, participants who benefited from the study treatment continued their treatment within the study upon transitioning into the LTE phase.
|
Arm B: Lazertinib With Amivantamab Intravenous (IV) Infusion
Participants were administered lazertinib 240 mg orally once daily from Cycle 1 Day 1 until Cycle 15, with each cycle consisting of 28 days. Participants then received amivantamab intravenous infusion at dose 1050 mg (if BW\< 80 kg) or 1400 mg (if BW \>=80 kg) on Cycle 1 Days 1-2 (split dose), 8, 15, 22, and on Days 1 and 15 of each subsequent cycle, starting from Cycle 2. After the completion of primary analysis, participants who benefited from the study treatment continued their treatment within the study upon transitioning into the LTE phase.
|
|---|---|---|
|
Overall Study
STARTED
|
206
|
212
|
|
Overall Study
Treated (Safety Analysis)
|
206
|
210
|
|
Overall Study
COMPLETED
|
43
|
62
|
|
Overall Study
NOT COMPLETED
|
163
|
150
|
Reasons for withdrawal
| Measure |
Arm A: Lazertinib With Amivantamab SC-CF
Participants were administered lazertinib 240 milligrams (mg) tablet orally once daily from Cycle 1 Day 1 until Cycle 15, with each cycle consisting of 28 days. Participants then received amivantamab subcutaneous injection with at dose 1600 mg (if body weight \[BW\] is less than \[\<\] 80 kilograms \[kg\]) or 2240 mg (if BW is greater than or equal to \[\>=\] 80 kg) co-formulated (SC-CF) with recombinant human hyaluronidase PH20 (rHuPH20) 160 milligrams per milliliter (mg/mL) through manual injection on Cycle 1 Days 1, 8, 15, and 22, and on Days 1 and 15 of each subsequent cycle, starting from Cycle 2. After the completion of primary analysis, participants who benefited from the study treatment continued their treatment within the study upon transitioning into the LTE phase.
|
Arm B: Lazertinib With Amivantamab Intravenous (IV) Infusion
Participants were administered lazertinib 240 mg orally once daily from Cycle 1 Day 1 until Cycle 15, with each cycle consisting of 28 days. Participants then received amivantamab intravenous infusion at dose 1050 mg (if BW\< 80 kg) or 1400 mg (if BW \>=80 kg) on Cycle 1 Days 1-2 (split dose), 8, 15, 22, and on Days 1 and 15 of each subsequent cycle, starting from Cycle 2. After the completion of primary analysis, participants who benefited from the study treatment continued their treatment within the study upon transitioning into the LTE phase.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
7
|
8
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Other-Ongoing
|
156
|
141
|
Baseline Characteristics
A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Arm A: Lazertinib With Amivantamab SC-CF
n=206 Participants
Participants were administered lazertinib 240 milligrams (mg) tablet orally once daily from Cycle 1 Day 1 until Cycle 15, with each cycle consisting of 28 days. Participants then received amivantamab subcutaneous injection with at dose 1600 mg (if body weight \[BW\] is less than \[\<\] 80 kilograms \[kg\]) or 2240 mg (if BW is greater than or equal to \[\>=\] 80 kg) co-formulated (SC-CF) with recombinant human hyaluronidase PH20 (rHuPH20) 160 milligrams per milliliter (mg/mL) through manual injection on Cycle 1 Days 1, 8, 15, and 22, and on Days 1 and 15 of each subsequent cycle, starting from Cycle 2. After the completion of primary analysis, participants who benefited from the study treatment continued their treatment within the study upon transitioning into the LTE phase.
|
Arm B: Lazertinib With Amivantamab Intravenous (IV) Infusion
n=212 Participants
Participants were administered lazertinib 240 mg orally once daily from Cycle 1 Day 1 until Cycle 15, with each cycle consisting of 28 days. Participants then received amivantamab intravenous infusion at dose 1050 mg (if BW\< 80 kg) or 1400 mg (if BW \>=80 kg) on Cycle 1 Days 1-2 (split dose), 8, 15, 22, and on Days 1 and 15 of each subsequent cycle, starting from Cycle 2. After the completion of primary analysis, participants who benefited from the study treatment continued their treatment within the study upon transitioning into the LTE phase.
|
Total
n=418 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=41 Participants
|
2 Participants
n=40 Participants
|
3 Participants
n=81 Participants
|
|
Age, Continuous
|
60.8 years
STANDARD_DEVIATION 9.76 • n=41 Participants
|
61.4 years
STANDARD_DEVIATION 10.71 • n=40 Participants
|
61.1 years
STANDARD_DEVIATION 10.25 • n=81 Participants
|
|
Age, Customized
<50 years
|
28 Participants
n=41 Participants
|
29 Participants
n=40 Participants
|
57 Participants
n=81 Participants
|
|
Age, Customized
50-64 years
|
105 Participants
n=41 Participants
|
91 Participants
n=40 Participants
|
196 Participants
n=81 Participants
|
|
Age, Customized
65-74 years
|
55 Participants
n=41 Participants
|
70 Participants
n=40 Participants
|
125 Participants
n=81 Participants
|
|
Age, Customized
>=75 years
|
18 Participants
n=41 Participants
|
22 Participants
n=40 Participants
|
40 Participants
n=81 Participants
|
|
Sex: Female, Male
Female
|
138 Participants
n=41 Participants
|
141 Participants
n=40 Participants
|
279 Participants
n=81 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=41 Participants
|
71 Participants
n=40 Participants
|
139 Participants
n=81 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=81 Participants
|
|
Race (NIH/OMB)
Asian
|
126 Participants
n=41 Participants
|
129 Participants
n=40 Participants
|
255 Participants
n=81 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=81 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=41 Participants
|
3 Participants
n=40 Participants
|
4 Participants
n=81 Participants
|
|
Race (NIH/OMB)
White
|
78 Participants
n=41 Participants
|
77 Participants
n=40 Participants
|
155 Participants
n=81 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
1 Participants
n=40 Participants
|
1 Participants
n=81 Participants
|
|
Region of Enrollment
Argentina
|
5 Participants
n=41 Participants
|
6 Participants
n=40 Participants
|
11 Participants
n=81 Participants
|
|
Region of Enrollment
Australia
|
12 Participants
n=41 Participants
|
5 Participants
n=40 Participants
|
17 Participants
n=81 Participants
|
|
Region of Enrollment
Brazil
|
6 Participants
n=41 Participants
|
11 Participants
n=40 Participants
|
17 Participants
n=81 Participants
|
|
Region of Enrollment
Canada
|
7 Participants
n=41 Participants
|
11 Participants
n=40 Participants
|
18 Participants
n=81 Participants
|
|
Region of Enrollment
China
|
46 Participants
n=41 Participants
|
47 Participants
n=40 Participants
|
93 Participants
n=81 Participants
|
|
Region of Enrollment
France
|
3 Participants
n=41 Participants
|
4 Participants
n=40 Participants
|
7 Participants
n=81 Participants
|
|
Region of Enrollment
Germany
|
2 Participants
n=41 Participants
|
3 Participants
n=40 Participants
|
5 Participants
n=81 Participants
|
|
Region of Enrollment
Israel
|
9 Participants
n=41 Participants
|
4 Participants
n=40 Participants
|
13 Participants
n=81 Participants
|
|
Region of Enrollment
Italy
|
13 Participants
n=41 Participants
|
14 Participants
n=40 Participants
|
27 Participants
n=81 Participants
|
|
Region of Enrollment
Japan
|
26 Participants
n=41 Participants
|
30 Participants
n=40 Participants
|
56 Participants
n=81 Participants
|
|
Region of Enrollment
Malaysia
|
8 Participants
n=41 Participants
|
9 Participants
n=40 Participants
|
17 Participants
n=81 Participants
|
|
Region of Enrollment
Poland
|
3 Participants
n=41 Participants
|
0 Participants
n=40 Participants
|
3 Participants
n=81 Participants
|
|
Region of Enrollment
Portugal
|
3 Participants
n=41 Participants
|
2 Participants
n=40 Participants
|
5 Participants
n=81 Participants
|
|
Region of Enrollment
Korea, South
|
21 Participants
n=41 Participants
|
20 Participants
n=40 Participants
|
41 Participants
n=81 Participants
|
|
Region of Enrollment
Spain
|
14 Participants
n=41 Participants
|
15 Participants
n=40 Participants
|
29 Participants
n=81 Participants
|
|
Region of Enrollment
Taiwan
|
6 Participants
n=41 Participants
|
6 Participants
n=40 Participants
|
12 Participants
n=81 Participants
|
|
Region of Enrollment
Thailand
|
5 Participants
n=41 Participants
|
2 Participants
n=40 Participants
|
7 Participants
n=81 Participants
|
|
Region of Enrollment
Turkey
|
5 Participants
n=41 Participants
|
2 Participants
n=40 Participants
|
7 Participants
n=81 Participants
|
|
Region of Enrollment
United Kingdom
|
0 Participants
n=41 Participants
|
2 Participants
n=40 Participants
|
2 Participants
n=81 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=41 Participants
|
19 Participants
n=40 Participants
|
31 Participants
n=81 Participants
|
PRIMARY outcome
Timeframe: Pre-dose on Cycle 4 Day 1 (each cycle of 28 days)Population: The pharmacokinetic (PK) primary endpoint evaluable set included all randomized participants who had received all doses in Cycle 1-3, without dose modifications and provided Cycle 4 Day 1 Ctrough. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
Ctrough was the observed serum concentration of Amivantamab at steady state immediately prior to the next drug administration.
Outcome measures
| Measure |
Arm A: Lazertinib With Amivantamab SC-CF
n=98 Participants
Participants were administered lazertinib 240 milligrams (mg) tablet orally once daily from Cycle 1 Day 1 until Cycle 15, with each cycle consisting of 28 days. Participants then received amivantamab subcutaneous injection with at dose 1600 mg (if body weight \[BW\] is less than \[\<\] 80 kilograms \[kg\]) or 2240 mg (if BW is greater than or equal to \[\>=\] 80 kg) co-formulated (SC-CF) with recombinant human hyaluronidase PH20 (rHuPH20) 160 milligrams per milliliter (mg/mL) through manual injection on Cycle 1 Days 1, 8, 15, and 22, and on Days 1 and 15 of each subsequent cycle, starting from Cycle 2. After the completion of primary analysis, participants who benefited from the study treatment continued their treatment within the study upon transitioning into the LTE phase.
|
Arm B: Lazertinib With Amivantamab Intravenous (IV) Infusion
n=98 Participants
Participants were administered lazertinib 240 mg orally once daily from Cycle 1 Day 1 until Cycle 15, with each cycle consisting of 28 days. Participants then received amivantamab intravenous infusion at dose 1050 mg (if BW\< 80 kg) or 1400 mg (if BW \>=80 kg) on Cycle 1 Days 1-2 (split dose), 8, 15, 22, and on Days 1 and 15 of each subsequent cycle, starting from Cycle 2. After the completion of primary analysis, participants who benefited from the study treatment continued their treatment within the study upon transitioning into the LTE phase.
|
|---|---|---|
|
For All Regions Other Than the European Union (EU) and Others Accepting Cycle 2 Day 1: Observed Serum Concentration (Ctrough) of Amivantamab at Steady State
|
206 micrograms per milliliters (mcg/mL)
Geometric Coefficient of Variation 39.1
|
144 micrograms per milliliters (mcg/mL)
Geometric Coefficient of Variation 41.5
|
PRIMARY outcome
Timeframe: Pre-dose on Cycle 2 Day 1 (each cycle of 28 days)Population: The PK primary endpoint evaluable set included all randomized participants who had received all doses in Cycle 1, without dose modifications and provided Cycle 2 Day 1 Ctrough. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
Ctrough was the observed serum concentration of Amivantamab immediately prior to the next drug administration.
Outcome measures
| Measure |
Arm A: Lazertinib With Amivantamab SC-CF
n=160 Participants
Participants were administered lazertinib 240 milligrams (mg) tablet orally once daily from Cycle 1 Day 1 until Cycle 15, with each cycle consisting of 28 days. Participants then received amivantamab subcutaneous injection with at dose 1600 mg (if body weight \[BW\] is less than \[\<\] 80 kilograms \[kg\]) or 2240 mg (if BW is greater than or equal to \[\>=\] 80 kg) co-formulated (SC-CF) with recombinant human hyaluronidase PH20 (rHuPH20) 160 milligrams per milliliter (mg/mL) through manual injection on Cycle 1 Days 1, 8, 15, and 22, and on Days 1 and 15 of each subsequent cycle, starting from Cycle 2. After the completion of primary analysis, participants who benefited from the study treatment continued their treatment within the study upon transitioning into the LTE phase.
|
Arm B: Lazertinib With Amivantamab Intravenous (IV) Infusion
n=142 Participants
Participants were administered lazertinib 240 mg orally once daily from Cycle 1 Day 1 until Cycle 15, with each cycle consisting of 28 days. Participants then received amivantamab intravenous infusion at dose 1050 mg (if BW\< 80 kg) or 1400 mg (if BW \>=80 kg) on Cycle 1 Days 1-2 (split dose), 8, 15, 22, and on Days 1 and 15 of each subsequent cycle, starting from Cycle 2. After the completion of primary analysis, participants who benefited from the study treatment continued their treatment within the study upon transitioning into the LTE phase.
|
|---|---|---|
|
For EU and Any Applicable Region: Observed Serum Concentration (Ctrough) of Amivantamab
|
335 mcg/mL
Geometric Coefficient of Variation 32.7
|
293 mcg/mL
Geometric Coefficient of Variation 31.7
|
PRIMARY outcome
Timeframe: Cycle 2: Arm A: pre-dose, 24, 48, 72, 96, 168, and 360 hours (hrs) post-dose on Day 1; Arm B: pre-infusion, end of infusion (EOI)+10 minutes, EOI+2, EOI+6, EOI+24, EOI+48, EOI+72, EOI+168, and EOI+360 hrs post dose on Day 1Population: The PK primary endpoint evaluable set included all randomized participants who had received all doses up to Cycle 2 Day 1, without dose modifications and provided all necessary PK samples to derive primary PK endpoint Cycle 2 AUC(D1-D15). Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
AUC (Day 1-15) defined as area under the concentration time curve from Cycle 2 Day 1 to Day 15 were reported.
Outcome measures
| Measure |
Arm A: Lazertinib With Amivantamab SC-CF
n=140 Participants
Participants were administered lazertinib 240 milligrams (mg) tablet orally once daily from Cycle 1 Day 1 until Cycle 15, with each cycle consisting of 28 days. Participants then received amivantamab subcutaneous injection with at dose 1600 mg (if body weight \[BW\] is less than \[\<\] 80 kilograms \[kg\]) or 2240 mg (if BW is greater than or equal to \[\>=\] 80 kg) co-formulated (SC-CF) with recombinant human hyaluronidase PH20 (rHuPH20) 160 milligrams per milliliter (mg/mL) through manual injection on Cycle 1 Days 1, 8, 15, and 22, and on Days 1 and 15 of each subsequent cycle, starting from Cycle 2. After the completion of primary analysis, participants who benefited from the study treatment continued their treatment within the study upon transitioning into the LTE phase.
|
Arm B: Lazertinib With Amivantamab Intravenous (IV) Infusion
n=132 Participants
Participants were administered lazertinib 240 mg orally once daily from Cycle 1 Day 1 until Cycle 15, with each cycle consisting of 28 days. Participants then received amivantamab intravenous infusion at dose 1050 mg (if BW\< 80 kg) or 1400 mg (if BW \>=80 kg) on Cycle 1 Days 1-2 (split dose), 8, 15, 22, and on Days 1 and 15 of each subsequent cycle, starting from Cycle 2. After the completion of primary analysis, participants who benefited from the study treatment continued their treatment within the study upon transitioning into the LTE phase.
|
|---|---|---|
|
Area Under the Concentration (AUC) Time Curve of Amivantamab From Day 1 to Day 15 (AUC [Day 1-15]) of Cycle 2
|
135861 micrograms*hour per milliliters
Geometric Coefficient of Variation 30.7
|
131704 micrograms*hour per milliliters
Geometric Coefficient of Variation 24.0
|
SECONDARY outcome
Timeframe: Up to 3 years 4 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 years 4 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 years 4 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 years 4 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 years 4 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 years 4 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 years 4 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 years 4 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 years 4 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 years 4 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose on Cycle 2 Day 1 (each cycle of 28 days)Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose on Cycle 4 Day 1 (each cycle of 28 days)Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 4: Arm A: pre-dose, 24, 48, 72, 96, 168, and 360 hrs post-dose on Day 1; Arm B: preinfusion, EOI+10 minutes, EOI+2, EOI+6, EOI+24, EOI+48, EOI+72, EOI+168, and EOI+360 hrs post dose on Day 1Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 years 4 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 years 4 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From baseline (Day 1, Cycle 1) to 3 years 4 months (each cycle of 28 days)Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 years 4 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 years 4 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 years 4 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 years 4 monthsOutcome measures
Outcome data not reported
Adverse Events
Arm A: Lazertinib With Amivantamab SC-CF
Serious events: 59 serious events
Other events: 201 other events
Deaths: 43 deaths
Arm B: Lazertinib With Amivantamab Intravenous (IV) Infusion
Serious events: 64 serious events
Other events: 207 other events
Deaths: 61 deaths
Serious adverse events
| Measure |
Arm A: Lazertinib With Amivantamab SC-CF
n=206 participants at risk
Participants were administered lazertinib 240 milligrams (mg) tablet orally once daily from Cycle 1 Day 1 until Cycle 15, with each cycle consisting of 28 days. Participants then received amivantamab subcutaneous injection with at dose 1600 mg (if body weight \[BW\] is less than \[\<\] 80 kilograms \[kg\]) or 2240 mg (if BW is greater than or equal to \[\>=\] 80 kg) co-formulated (SC-CF) with recombinant human hyaluronidase PH20 (rHuPH20) 160 milligrams per milliliter (mg/mL) through manual injection on Cycle 1 Days 1, 8, 15, and 22, and on Days 1 and 15 of each subsequent cycle, starting from Cycle 2. After the completion of primary analysis, participants who benefited from the study treatment continued their treatment within the study upon transitioning into the LTE phase.
|
Arm B: Lazertinib With Amivantamab Intravenous (IV) Infusion
n=210 participants at risk
Participants were administered lazertinib 240 mg orally once daily from Cycle 1 Day 1 until Cycle 15, with each cycle consisting of 28 days. Participants then received amivantamab intravenous infusion at dose 1050 mg (if BW\< 80 kg) or 1400 mg (if BW \>=80 kg) on Cycle 1 Days 1-2 (split dose), 8, 15, 22, and on Days 1 and 15 of each subsequent cycle, starting from Cycle 2. After the completion of primary analysis, participants who benefited from the study treatment continued their treatment within the study upon transitioning into the LTE phase.
|
|---|---|---|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.49%
1/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.48%
1/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.48%
1/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac Arrest
|
0.49%
1/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Ischaemic Cardiomyopathy
|
0.49%
1/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.48%
1/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Eye disorders
Diplopia
|
0.00%
0/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.48%
1/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.49%
1/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.48%
1/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.49%
1/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastritis
|
0.49%
1/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haematemesis
|
0.49%
1/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Ileus
|
0.49%
1/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Lower Gastrointestinal Haemorrhage
|
0.00%
0/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.48%
1/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
3/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Oesophageal Stenosis
|
0.49%
1/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.97%
2/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Asthenia
|
0.97%
2/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.95%
2/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
1.5%
3/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.48%
1/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
0.49%
1/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.48%
1/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Sudden Death
|
0.49%
1/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.48%
1/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.49%
1/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.48%
1/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.48%
1/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.48%
1/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bacterial Infection
|
0.49%
1/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.48%
1/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Clostridium Difficile Infection
|
0.00%
0/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.48%
1/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Covid-19
|
1.9%
4/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
1.9%
4/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Herpes Simplex
|
0.49%
1/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.00%
0/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.48%
1/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Myiasis
|
0.49%
1/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Oral Infection
|
0.49%
1/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
1.5%
3/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
3.3%
7/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia Aspiration
|
0.00%
0/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.48%
1/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia Viral
|
0.49%
1/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pulmonary Tuberculosis
|
0.49%
1/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Respiratory Tract Infection
|
0.00%
0/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.48%
1/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sepsis
|
0.00%
0/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.48%
1/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Skin Infection
|
0.49%
1/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.95%
2/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.48%
1/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.48%
1/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.49%
1/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.49%
1/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.97%
2/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction
|
0.00%
0/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.95%
2/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Radiation Pneumonitis
|
0.49%
1/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Alanine Aminotransferase Increased
|
1.9%
4/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
3/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.49%
1/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.95%
2/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
0.49%
1/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
0.49%
1/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.48%
1/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.49%
1/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.95%
2/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.48%
1/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.49%
1/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.48%
1/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.49%
1/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.95%
2/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.48%
1/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.49%
1/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Cerebral Infarction
|
0.00%
0/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
1.4%
3/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Epilepsy
|
0.49%
1/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
0.49%
1/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Ischaemic Cerebral Infarction
|
0.00%
0/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.48%
1/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Ischaemic Stroke
|
0.49%
1/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Presyncope
|
0.49%
1/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Spinal Cord Compression
|
0.00%
0/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.48%
1/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.48%
1/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.48%
1/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.48%
1/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.49%
1/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.95%
2/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.49%
1/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.48%
1/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial Lung Disease
|
1.5%
3/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.48%
1/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.49%
1/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.48%
1/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.4%
9/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
2.9%
6/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.49%
1/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.48%
1/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.49%
1/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.95%
2/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Infarction
|
0.00%
0/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.48%
1/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Disorder
|
0.49%
1/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.97%
2/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.48%
1/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.48%
1/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.95%
2/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
0.49%
1/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Capillary Leak Syndrome
|
0.00%
0/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.48%
1/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.97%
2/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
1.9%
4/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Embolism Arterial
|
0.00%
0/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.48%
1/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.48%
1/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.48%
1/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.48%
1/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Venous Thrombosis Limb
|
0.49%
1/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Arm A: Lazertinib With Amivantamab SC-CF
n=206 participants at risk
Participants were administered lazertinib 240 milligrams (mg) tablet orally once daily from Cycle 1 Day 1 until Cycle 15, with each cycle consisting of 28 days. Participants then received amivantamab subcutaneous injection with at dose 1600 mg (if body weight \[BW\] is less than \[\<\] 80 kilograms \[kg\]) or 2240 mg (if BW is greater than or equal to \[\>=\] 80 kg) co-formulated (SC-CF) with recombinant human hyaluronidase PH20 (rHuPH20) 160 milligrams per milliliter (mg/mL) through manual injection on Cycle 1 Days 1, 8, 15, and 22, and on Days 1 and 15 of each subsequent cycle, starting from Cycle 2. After the completion of primary analysis, participants who benefited from the study treatment continued their treatment within the study upon transitioning into the LTE phase.
|
Arm B: Lazertinib With Amivantamab Intravenous (IV) Infusion
n=210 participants at risk
Participants were administered lazertinib 240 mg orally once daily from Cycle 1 Day 1 until Cycle 15, with each cycle consisting of 28 days. Participants then received amivantamab intravenous infusion at dose 1050 mg (if BW\< 80 kg) or 1400 mg (if BW \>=80 kg) on Cycle 1 Days 1-2 (split dose), 8, 15, 22, and on Days 1 and 15 of each subsequent cycle, starting from Cycle 2. After the completion of primary analysis, participants who benefited from the study treatment continued their treatment within the study upon transitioning into the LTE phase.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
18.9%
39/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
19.0%
40/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.8%
12/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
3.8%
8/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
3.9%
8/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
9.0%
19/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.8%
12/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
3.8%
8/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
14.1%
29/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
15.7%
33/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
20.4%
42/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
20.0%
42/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
20.9%
43/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
18.6%
39/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gingival Bleeding
|
7.8%
16/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
6.2%
13/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
5.8%
12/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
2.9%
6/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
29.1%
60/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
24.8%
52/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
27.7%
57/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
32.9%
69/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
20.9%
43/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
19.5%
41/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Asthenia
|
15.0%
31/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
10.0%
21/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
20.9%
43/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
20.0%
42/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Malaise
|
8.3%
17/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
5.2%
11/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Oedema Peripheral
|
25.2%
52/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
27.6%
58/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
11.7%
24/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
9.5%
20/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
7.3%
15/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
2.9%
6/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Conjunctivitis
|
6.8%
14/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
4.8%
10/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Covid-19
|
6.3%
13/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
7.1%
15/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Paronychia
|
53.9%
111/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
51.4%
108/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary Tract Infection
|
1.9%
4/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
5.2%
11/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Administration Related Reaction
|
9.7%
20/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction
|
13.1%
27/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
65.2%
137/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Alanine Aminotransferase Increased
|
22.3%
46/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
25.7%
54/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Aspartate Aminotransferase Increased
|
20.4%
42/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
21.0%
44/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
10.7%
22/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
9.5%
20/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Blood Creatinine Increased
|
7.3%
15/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
6.7%
14/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Blood Lactate Dehydrogenase Increased
|
9.2%
19/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
6.2%
13/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
10.2%
21/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
6.7%
14/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Weight Decreased
|
12.1%
25/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
7.1%
15/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
21.8%
45/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
24.8%
52/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.8%
12/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
3.8%
8/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
46.6%
96/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
36.2%
76/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
16.0%
33/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
12.9%
27/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.2%
21/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
9.0%
19/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
10.2%
21/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
7.1%
15/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
8.3%
17/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
10.0%
21/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.3%
13/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
3.3%
7/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
8.3%
17/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
10.5%
22/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
8.3%
17/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
5.7%
12/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
15.5%
32/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
6.2%
13/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
12.6%
26/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
9.5%
20/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
11.2%
23/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
11.4%
24/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
20.4%
42/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
17.1%
36/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
3.9%
8/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
5.2%
11/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
7.8%
16/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
9.0%
19/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
7.3%
15/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
8.1%
17/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.8%
16/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
8.1%
17/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.3%
15/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
8.1%
17/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.7%
20/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
7.1%
15/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Acneiform
|
31.1%
64/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
32.9%
69/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
11.7%
24/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
11.9%
25/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.0%
33/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
11.9%
25/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
46.1%
95/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
43.3%
91/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
5.3%
11/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
4.8%
10/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin Fissures
|
7.3%
15/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
7.1%
15/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
2.9%
6/206 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
10.0%
21/210 • All cause mortality: From baseline (Day 1) up to 17 months; SAEs and other AEs: From baseline (Day 1) up to 8 months
Safety analysis set included all randomized participants who received at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
- Publication restrictions are in place
Restriction type: OTHER