Trial Outcomes & Findings for Premedication to Reduce Amivantamab Associated Infusion Related Reactions (NCT NCT05663866)
NCT ID: NCT05663866
Last Updated: 2025-11-12
Results Overview
Percentage of participants with IRRs at Cycle 1 Day 1 was reported. IRRs were defined as IRR events with onset time within 24 hours of the start of the first amivantamab infusion and prior to the start of amivantamab infusion on Cycle 1 Day 2. IRR included chills, dyspnea, flushing, nausea, chest discomfort, vomiting, tachycardia, hypotension, and fever. IRRs that occurred on Cycle 1 Day 2 pre-infusion were considered under Cycle 1 Day 1.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
68 participants
Primary outcome timeframe
Cycle 1 Day 1 (each cycle of 28 days)
Results posted on
2025-11-12
Participant Flow
Participant milestones
| Measure |
Cohort A: Dexamethasone 4 Milligrams (mg)
Participants were administered with oral dexamethasone 4 mg tablet as a prophylactic treatment twice a day (8 mg total daily dose) on Day -1 (Cycle 1) prior to combination therapy of lazertinib 240 mg oral tablets and IV infusion of amivantamab 1050 mg (for participants less than \[\<\] 80 kilograms \[kg\]) or 1400 mg (for participants greater than or equal to \[\>=\] 80 kg) on Cycle 1 Day 1 until disease progression or withdrawal from study. Each cycle was of 28 days.
|
Cohort A2: Dexamethasone 8 mg
Participants were administered with oral dexamethasone 8 mg tablet as a prophylactic treatment twice a day (16 mg total daily dose) on Day -2 and -1 (Cycle 1) and 8 mg approximately one hour prior to IV infusion of amivantamab 1050 mg (for participants \<80 kg) or 1400 mg (for participants \>=80 kg) on Cycle 1 Day 1 until disease progression or withdrawal from study. Each cycle was of 28 days.
|
Cohort B: Montelukast 10 mg
Participants were administered with oral montelukast 10 mg tablet as a prophylactic treatment once daily in the morning on Days - 4, -3, -2, -1, and Cycle 1 Day 1 prior to combination therapy of lazertinib 240 mg oral tablets and IV infusion of amivantamab 1050 mg (for participants \<80 kg) or 1400 mg (for participants \>=80 kg) on Cycle 1 Day 1 until disease progression or withdrawal from study. Each cycle was of 28 days.
|
Cohort C: Methotrexate 25 mg
Participants were administered with a single dose of methotrexate 25 mg subcutaneous injection as a prophylactic treatment on any day between Days -7 and Day -3 (Cycle 1) prior to combination therapy of lazertinib 240 mg oral tablets and IV infusion of amivantamab 1050 mg (for participants \<80 kg) or 1400 mg (for participants \>=80 kg) on Cycle 1 Day 1 until disease progression or withdrawal from study. Each cycle was of 28 days.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
41
|
15
|
6
|
|
Overall Study
COMPLETED
|
0
|
4
|
2
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
37
|
13
|
6
|
Reasons for withdrawal
| Measure |
Cohort A: Dexamethasone 4 Milligrams (mg)
Participants were administered with oral dexamethasone 4 mg tablet as a prophylactic treatment twice a day (8 mg total daily dose) on Day -1 (Cycle 1) prior to combination therapy of lazertinib 240 mg oral tablets and IV infusion of amivantamab 1050 mg (for participants less than \[\<\] 80 kilograms \[kg\]) or 1400 mg (for participants greater than or equal to \[\>=\] 80 kg) on Cycle 1 Day 1 until disease progression or withdrawal from study. Each cycle was of 28 days.
|
Cohort A2: Dexamethasone 8 mg
Participants were administered with oral dexamethasone 8 mg tablet as a prophylactic treatment twice a day (16 mg total daily dose) on Day -2 and -1 (Cycle 1) and 8 mg approximately one hour prior to IV infusion of amivantamab 1050 mg (for participants \<80 kg) or 1400 mg (for participants \>=80 kg) on Cycle 1 Day 1 until disease progression or withdrawal from study. Each cycle was of 28 days.
|
Cohort B: Montelukast 10 mg
Participants were administered with oral montelukast 10 mg tablet as a prophylactic treatment once daily in the morning on Days - 4, -3, -2, -1, and Cycle 1 Day 1 prior to combination therapy of lazertinib 240 mg oral tablets and IV infusion of amivantamab 1050 mg (for participants \<80 kg) or 1400 mg (for participants \>=80 kg) on Cycle 1 Day 1 until disease progression or withdrawal from study. Each cycle was of 28 days.
|
Cohort C: Methotrexate 25 mg
Participants were administered with a single dose of methotrexate 25 mg subcutaneous injection as a prophylactic treatment on any day between Days -7 and Day -3 (Cycle 1) prior to combination therapy of lazertinib 240 mg oral tablets and IV infusion of amivantamab 1050 mg (for participants \<80 kg) or 1400 mg (for participants \>=80 kg) on Cycle 1 Day 1 until disease progression or withdrawal from study. Each cycle was of 28 days.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
1
|
2
|
|
Overall Study
Progressive disease
|
4
|
8
|
5
|
2
|
|
Overall Study
Other
|
1
|
0
|
0
|
0
|
|
Overall Study
Ongoing
|
1
|
27
|
6
|
1
|
Baseline Characteristics
Premedication to Reduce Amivantamab Associated Infusion Related Reactions
Baseline characteristics by cohort
| Measure |
Cohort A: Dexamethasone 4 Milligrams (mg)
n=6 Participants
Participants were administered with oral dexamethasone 4 mg tablet as a prophylactic treatment twice a day (8 mg total daily dose) on Day -1 (Cycle 1) prior to combination therapy of lazertinib 240 mg oral tablets and IV infusion of amivantamab 1050 mg (for participants less than \[\<\] 80 kilograms \[kg\]) or 1400 mg (for participants greater than or equal to \[\>=\] 80 kg) on Cycle 1 Day 1 until disease progression or withdrawal from study. Each cycle was of 28 days.
|
Cohort A2: Dexamethasone 8 mg
n=41 Participants
Participants were administered with oral dexamethasone 8 mg tablet as a prophylactic treatment twice a day (16 mg total daily dose) on Day -2 and -1 (Cycle 1) and 8 mg approximately one hour prior to IV infusion of amivantamab 1050 mg (for participants \<80 kg) or 1400 mg (for participants \>=80 kg) on Cycle 1 Day 1 until disease progression or withdrawal from study. Each cycle was of 28 days.
|
Cohort B: Montelukast 10 mg
n=15 Participants
Participants were administered with oral montelukast 10 mg tablet as a prophylactic treatment once daily in the morning on Days - 4, -3, -2, -1, and Cycle 1 Day 1 prior to combination therapy of lazertinib 240 mg oral tablets and IV infusion of amivantamab 1050 mg (for participants \<80 kg) or 1400 mg (for participants \>=80 kg) on Cycle 1 Day 1 until disease progression or withdrawal from study. Each cycle was of 28 days.
|
Cohort C: Methotrexate 25 mg
n=6 Participants
Participants were administered with a single dose of methotrexate 25 mg subcutaneous injection as a prophylactic treatment on any day between Days -7 and Day -3 (Cycle 1) prior to combination therapy of lazertinib 240 mg oral tablets and IV infusion of amivantamab 1050 mg (for participants \<80 kg) or 1400 mg (for participants \>=80 kg) on Cycle 1 Day 1 until disease progression or withdrawal from study. Each cycle was of 28 days.
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
58.2 years
STANDARD_DEVIATION 13.60 • n=10 Participants
|
62.0 years
STANDARD_DEVIATION 9.68 • n=10 Participants
|
65.0 years
STANDARD_DEVIATION 8.72 • n=20 Participants
|
66.2 years
STANDARD_DEVIATION 11.96 • n=45 Participants
|
62.7 years
STANDARD_DEVIATION 10.04 • n=44 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=10 Participants
|
26 Participants
n=10 Participants
|
10 Participants
n=20 Participants
|
5 Participants
n=45 Participants
|
44 Participants
n=44 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=10 Participants
|
15 Participants
n=10 Participants
|
5 Participants
n=20 Participants
|
1 Participants
n=45 Participants
|
24 Participants
n=44 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=10 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
6 Participants
n=44 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=10 Participants
|
31 Participants
n=10 Participants
|
13 Participants
n=20 Participants
|
6 Participants
n=45 Participants
|
53 Participants
n=44 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=10 Participants
|
8 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
9 Participants
n=44 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=10 Participants
|
24 Participants
n=10 Participants
|
10 Participants
n=20 Participants
|
6 Participants
n=45 Participants
|
42 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
1 Participants
n=44 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
4 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
18 Participants
n=44 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
6 Participants
n=10 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
7 Participants
n=44 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1 (each cycle of 28 days)Population: The per protocol analysis set included all participants who had received all prophylaxis treatment based on schedule and had received the administration of amivantamab and lazertinib on Cycle 1 Day 1.
Percentage of participants with IRRs at Cycle 1 Day 1 was reported. IRRs were defined as IRR events with onset time within 24 hours of the start of the first amivantamab infusion and prior to the start of amivantamab infusion on Cycle 1 Day 2. IRR included chills, dyspnea, flushing, nausea, chest discomfort, vomiting, tachycardia, hypotension, and fever. IRRs that occurred on Cycle 1 Day 2 pre-infusion were considered under Cycle 1 Day 1.
Outcome measures
| Measure |
Cohort A: Dexamethasone 4 Milligrams (mg)
n=6 Participants
Participants were administered with oral dexamethasone 4 mg tablet as a prophylactic treatment twice a day (8 mg total daily dose) on Day -1 (Cycle 1) prior to combination therapy of lazertinib 240 mg oral tablets and IV infusion of amivantamab 1050 mg (for participants less than \[\<\] 80 kilograms \[kg\]) or 1400 mg (for participants greater than or equal to \[\>=\] 80 kg) on Cycle 1 Day 1 until disease progression or withdrawal from study. Each cycle was of 28 days.
|
Cohort A2: Dexamethasone 8 mg
n=40 Participants
Participants were administered with oral dexamethasone 8 mg tablet as a prophylactic treatment twice a day (16 mg total daily dose) on Day -2 and -1 (Cycle 1) and 8 mg approximately one hour prior to IV infusion of amivantamab 1050 mg (for participants \<80 kg) or 1400 mg (for participants \>=80 kg) on Cycle 1 Day 1 until disease progression or withdrawal from study. Each cycle was of 28 days.
|
Cohort B: Montelukast 10 mg
n=15 Participants
Participants were administered with oral montelukast 10 mg tablet as a prophylactic treatment once daily in the morning on Days - 4, -3, -2, -1, and Cycle 1 Day 1 prior to combination therapy of lazertinib 240 mg oral tablets and IV infusion of amivantamab 1050 mg (for participants \<80 kg) or 1400 mg (for participants \>=80 kg) on Cycle 1 Day 1 until disease progression or withdrawal from study. Each cycle was of 28 days.
|
Cohort C: Methotrexate 25 mg
n=6 Participants
Participants were administered with a single dose of methotrexate 25 mg subcutaneous injection as a prophylactic treatment on any day between Days -7 and Day -3 (Cycle 1) prior to combination therapy of lazertinib 240 mg oral tablets and IV infusion of amivantamab 1050 mg (for participants \<80 kg) or 1400 mg (for participants \>=80 kg) on Cycle 1 Day 1 until disease progression or withdrawal from study. Each cycle was of 28 days.
|
|---|---|---|---|---|
|
Percentage of Participants With Infusion-related Reactions (IRRs) at Cycle 1 Day 1
|
83.3 Percentage of participants
Interval 35.9 to 99.6
|
22.5 Percentage of participants
Interval 10.8 to 38.5
|
66.7 Percentage of participants
Interval 38.4 to 88.2
|
83.3 Percentage of participants
Interval 35.9 to 99.6
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 (each cycle of 28 days)Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Cycle 1 Day 1 up to Cycle 3 Day 28 (each cycle of 28 days)Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Cycle 1 Day 1 (each cycle of 28 days) up to 27.3 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Cycle 1 Day 1 (each cycle of 28 days) up to 28.3 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1 Day 1 (each cycle of 28 days)Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 4 hours on Cycle 1 Day 1 (each cycle of 28 days)Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Cycle 1 Day 1 (each cycle of 28 days) up to 28.3 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Cycle 1 Day 1 (each cycle of 28 days) up to 28.3 monthsOutcome measures
Outcome data not reported
Adverse Events
Cohort A1: Dexamethasone 4 Milligrams (mg)
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort A2: Dexamethasone 8 mg
Serious events: 20 serious events
Other events: 41 other events
Deaths: 4 deaths
Cohort B: Montelukast 10 mg
Serious events: 5 serious events
Other events: 15 other events
Deaths: 2 deaths
Cohort C: Methotrexate 25 mg
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort A1: Dexamethasone 4 Milligrams (mg)
n=6 participants at risk
Participants were administered with oral dexamethasone 4 mg tablet as a prophylactic treatment twice a day (8 mg total daily dose) on Day -1 (Cycle 1) prior to combination therapy of lazertinib 240 mg oral tablets and IV infusion of amivantamab 1050 mg (for participants less than \[\<\] 80 kilograms \[kg\]) or 1400 mg (for participants greater than or equal to \[\>=\] 80 kg) on Cycle 1 Day 1 until disease progression or withdrawal from study. Each cycle was of 28 days.
|
Cohort A2: Dexamethasone 8 mg
n=41 participants at risk
Participants were administered with oral dexamethasone 8 mg tablet as a prophylactic treatment twice a day (16 mg total daily dose) on Day -2 and -1 (Cycle 1) and 8 mg approximately one hour prior to IV infusion of amivantamab 1050 mg (for participants \<80 kg) or 1400 mg (for participants \>=80 kg) on Cycle 1 Day 1 until disease progression or withdrawal from study. Each cycle was of 28 days.
|
Cohort B: Montelukast 10 mg
n=15 participants at risk
Participants were administered with oral montelukast 10 mg tablet as a prophylactic treatment once daily in the morning on Days - 4, -3, -2, -1, and Cycle 1 Day 1 prior to combination therapy of lazertinib 240 mg oral tablets and IV infusion of amivantamab 1050 mg (for participants \<80 kg) or 1400 mg (for participants \>=80 kg) on Cycle 1 Day 1 until disease progression or withdrawal from study. Each cycle was of 28 days.
|
Cohort C: Methotrexate 25 mg
n=6 participants at risk
Participants were administered with a single dose of methotrexate 25 mg subcutaneous injection as a prophylactic treatment on any day between Days -7 and Day -3 (Cycle 1) prior to combination therapy of lazertinib 240 mg oral tablets and IV infusion of amivantamab 1050 mg (for participants \<80 kg) or 1400 mg (for participants \>=80 kg) on Cycle 1 Day 1 until disease progression or withdrawal from study. Each cycle was of 28 days.
|
|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
4.9%
2/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
2.4%
1/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Infections and infestations
Empyema
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Infections and infestations
Pneumonia Aspiration
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Infections and infestations
Pneumonia Bacterial
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Infections and infestations
Respiratory Tract Infection
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
2.4%
1/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Infections and infestations
Skin Infection
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
2.4%
1/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Infections and infestations
Subcutaneous Abscess
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
2.4%
1/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
2.4%
1/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
2.4%
1/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
2.4%
1/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
2.4%
1/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
2.4%
1/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
2.4%
1/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
2.4%
1/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
2.4%
1/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
2.4%
1/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
2.4%
1/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
13.3%
2/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
General disorders
Fatigue
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Nervous system disorders
Spinal Cord Compression
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
4.9%
2/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Nervous system disorders
Cerebral Infarction
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
2.4%
1/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
2.4%
1/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
2.4%
1/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
2.4%
1/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic Fracture
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
2.4%
1/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
2.4%
1/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
2.4%
1/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Psychiatric disorders
Abnormal Behaviour
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
2.4%
1/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
2.4%
1/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
Other adverse events
| Measure |
Cohort A1: Dexamethasone 4 Milligrams (mg)
n=6 participants at risk
Participants were administered with oral dexamethasone 4 mg tablet as a prophylactic treatment twice a day (8 mg total daily dose) on Day -1 (Cycle 1) prior to combination therapy of lazertinib 240 mg oral tablets and IV infusion of amivantamab 1050 mg (for participants less than \[\<\] 80 kilograms \[kg\]) or 1400 mg (for participants greater than or equal to \[\>=\] 80 kg) on Cycle 1 Day 1 until disease progression or withdrawal from study. Each cycle was of 28 days.
|
Cohort A2: Dexamethasone 8 mg
n=41 participants at risk
Participants were administered with oral dexamethasone 8 mg tablet as a prophylactic treatment twice a day (16 mg total daily dose) on Day -2 and -1 (Cycle 1) and 8 mg approximately one hour prior to IV infusion of amivantamab 1050 mg (for participants \<80 kg) or 1400 mg (for participants \>=80 kg) on Cycle 1 Day 1 until disease progression or withdrawal from study. Each cycle was of 28 days.
|
Cohort B: Montelukast 10 mg
n=15 participants at risk
Participants were administered with oral montelukast 10 mg tablet as a prophylactic treatment once daily in the morning on Days - 4, -3, -2, -1, and Cycle 1 Day 1 prior to combination therapy of lazertinib 240 mg oral tablets and IV infusion of amivantamab 1050 mg (for participants \<80 kg) or 1400 mg (for participants \>=80 kg) on Cycle 1 Day 1 until disease progression or withdrawal from study. Each cycle was of 28 days.
|
Cohort C: Methotrexate 25 mg
n=6 participants at risk
Participants were administered with a single dose of methotrexate 25 mg subcutaneous injection as a prophylactic treatment on any day between Days -7 and Day -3 (Cycle 1) prior to combination therapy of lazertinib 240 mg oral tablets and IV infusion of amivantamab 1050 mg (for participants \<80 kg) or 1400 mg (for participants \>=80 kg) on Cycle 1 Day 1 until disease progression or withdrawal from study. Each cycle was of 28 days.
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
2/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
41.5%
17/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
53.3%
8/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
50.0%
3/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
2/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
12.2%
5/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
20.0%
3/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
66.7%
4/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Acneiform
|
33.3%
2/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
17.1%
7/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
20.0%
3/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
14.6%
6/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
20.0%
3/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
2/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
9.8%
4/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
2.4%
1/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
33.3%
2/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Skin and subcutaneous tissue disorders
Skin Fissures
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
9.8%
4/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
4.9%
2/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
13.3%
2/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
2.4%
1/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Skin and subcutaneous tissue disorders
Rash Pruritic
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic Dermatitis
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
2.4%
1/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Skin and subcutaneous tissue disorders
Xeroderma
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
2.4%
1/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysaesthesia Syndrome
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Skin and subcutaneous tissue disorders
Rash Erythematous
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
General disorders
Chills
|
33.3%
2/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
40.0%
6/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
33.3%
2/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Skin and subcutaneous tissue disorders
Skin Necrosis
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
2/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
24.4%
10/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
40.0%
6/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
66.7%
4/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Gastrointestinal disorders
Stomatitis
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
34.1%
14/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
20.0%
3/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
33.3%
2/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
2/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
19.5%
8/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
17.1%
7/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
13.3%
2/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
33.3%
2/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
12.2%
5/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
13.3%
2/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Gastrointestinal disorders
Gingival Bleeding
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
9.8%
4/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
13.3%
2/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Gastrointestinal disorders
Mouth Ulceration
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
7.3%
3/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
2.4%
1/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
13.3%
2/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
4.9%
2/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Gastrointestinal disorders
Dysphagia
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
2.4%
1/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Gastrointestinal disorders
Haemorrhoidal Haemorrhage
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Gastrointestinal disorders
Mouth Haemorrhage
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Gastrointestinal disorders
Proctalgia
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Infections and infestations
Paronychia
|
33.3%
2/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
39.0%
16/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
66.7%
10/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
33.3%
2/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Infections and infestations
Covid-19
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
2.4%
1/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
33.3%
5/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
7.3%
3/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
20.0%
3/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
7.3%
3/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
7.3%
3/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Infections and infestations
Nasopharyngitis
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
13.3%
2/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Infections and infestations
Eye Infection
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Infections and infestations
Influenza
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Infections and infestations
Rash Pustular
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Infections and infestations
Respiratory Tract Infection
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
General disorders
Oedema Peripheral
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
22.0%
9/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
33.3%
5/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
General disorders
Asthenia
|
33.3%
2/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
17.1%
7/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
20.0%
3/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
General disorders
Chest Discomfort
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
2.4%
1/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
13.3%
2/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
66.7%
4/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
General disorders
Fatigue
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
7.3%
3/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
20.0%
3/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
General disorders
Pyrexia
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
2.4%
1/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
13.3%
2/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
General disorders
Malaise
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
4.9%
2/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
General disorders
Infusion Site Extravasation
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
2.4%
1/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
General disorders
Feeling Hot
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
General disorders
Lithiasis
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
General disorders
Localised Oedema
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
General disorders
Non-Cardiac Chest Pain
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
General disorders
Temperature Regulation Disorder
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
22.0%
9/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
20.0%
3/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
2/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
17.1%
7/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
9.8%
4/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
33.3%
5/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
2.4%
1/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
33.3%
2/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
7.3%
3/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
4.9%
2/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
13.3%
2/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
13.3%
2/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
2.4%
1/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
13.3%
2/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
2.4%
1/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
9.8%
4/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
26.7%
4/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
33.3%
2/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal Haemorrhage
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Fibrosis
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
41.5%
17/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
26.7%
4/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
33.3%
2/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
2.4%
1/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Nervous system disorders
Hypoaesthesia
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
19.5%
8/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
26.7%
4/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
19.5%
8/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
4.9%
2/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
13.3%
2/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
50.0%
3/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Nervous system disorders
Paraesthesia
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
7.3%
3/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
13.3%
2/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
4.9%
2/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Nervous system disorders
Petit Mal Epilepsy
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Nervous system disorders
Tremor
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
12.2%
5/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
20.0%
3/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
12.2%
5/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
13.3%
2/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
7.3%
3/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Eye disorders
Dry Eye
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
4.9%
2/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
9.8%
4/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
2.4%
1/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
13.3%
2/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
19.5%
8/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Vascular disorders
Flushing
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
2.4%
1/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
13.3%
2/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Vascular disorders
Deep Vein Thrombosis
|
33.3%
2/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
2.4%
1/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Vascular disorders
Hypertension
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Vascular disorders
Orthostatic Hypotension
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Vascular disorders
Venous Thrombosis
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Investigations
Alanine Aminotransferase Increased
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
12.2%
5/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
13.3%
2/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Investigations
Aspartate Aminotransferase Increased
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
12.2%
5/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
13.3%
2/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
4.9%
2/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
13.3%
2/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Investigations
Blood Creatinine Increased
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Investigations
Blood Creatine Increased
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Blood and lymphatic system disorders
Anaemia
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
7.3%
3/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
12.2%
5/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Eye disorders
Trichiasis
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Eye disorders
Eye Pain
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
16.7%
1/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
2.4%
1/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
2.4%
1/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
13.3%
2/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Cardiac disorders
Sinus Tachycardia
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
2.4%
1/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Ear and labyrinth disorders
Ear Inflammation
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
|
Reproductive system and breast disorders
Genital Rash
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/41 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
6.7%
1/15 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
0.00%
0/6 • From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
|
Additional Information
Senior Medical Director Global Medical Affair Oncology
Janssen Research & Development LLC
Phone: 844-434-4210
Email: [email protected]
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