Trial Outcomes & Findings for Study of the Safety and Efficacy of Amatuximab in Combination With Pemetrexed and Cisplatin in Subjects With Unresectable Malignant Pleural Mesothelioma (MPM) (NCT NCT02357147)
NCT ID: NCT02357147
Last Updated: 2020-03-17
Results Overview
AEs included both non-SAEs and SAEs and the same participant can have both SAEs and as well non-SAEs.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
124 participants
Primary outcome timeframe
Baseline up to 3 years
Results posted on
2020-03-17
Participant Flow
Participants took part in the study at 36 investigative sites in the United States, France, Germany, Italy, the United Kingdom, and Australia from 03 November 2015 to 30 November 2018.
A total of 124 participants were enrolled (signed informed consent form), of which, 16 were screen failures, 108 were randomized, and 106 were treated. Deaths that were primary cause of treatment discontinuation are reported in participant flow excluding those that occurred after treatment discontinuation.
Participant milestones
| Measure |
Amatuximab + Pemetrexed + Cisplatin
During Combination Treatment Phase, participants received amatuximab 5 milligram per kilogram (mg/kg), infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 milligram per square meter (mg/m\^2) and cisplatin 75 mg/m\^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles. Following completion of the Combination Treatment Phase, participants who had not progressed entered the Maintenance Phase and continued to receive amatuximab 5 mg/kg, infusion, intravenously, once weekly until disease progression.
|
Placebo + Pemetrexed + Cisplatin
During Combination Treatment Phase, participants received placebo matched to amatuximab infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles. Following completion of the Combination Treatment Phase, participants who had not progressed entered the Maintenance Phase and received placebo matched to amatuximab infusion, intravenously, once weekly until disease progression.
|
|---|---|---|
|
Combination Treatment Phase
STARTED
|
52
|
56
|
|
Combination Treatment Phase
Treated
|
52
|
54
|
|
Combination Treatment Phase
COMPLETED
|
26
|
29
|
|
Combination Treatment Phase
NOT COMPLETED
|
26
|
27
|
|
Maintenance Treatment Phase
STARTED
|
26
|
29
|
|
Maintenance Treatment Phase
Treated
|
25
|
29
|
|
Maintenance Treatment Phase
COMPLETED
|
0
|
0
|
|
Maintenance Treatment Phase
NOT COMPLETED
|
26
|
29
|
Reasons for withdrawal
| Measure |
Amatuximab + Pemetrexed + Cisplatin
During Combination Treatment Phase, participants received amatuximab 5 milligram per kilogram (mg/kg), infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 milligram per square meter (mg/m\^2) and cisplatin 75 mg/m\^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles. Following completion of the Combination Treatment Phase, participants who had not progressed entered the Maintenance Phase and continued to receive amatuximab 5 mg/kg, infusion, intravenously, once weekly until disease progression.
|
Placebo + Pemetrexed + Cisplatin
During Combination Treatment Phase, participants received placebo matched to amatuximab infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles. Following completion of the Combination Treatment Phase, participants who had not progressed entered the Maintenance Phase and received placebo matched to amatuximab infusion, intravenously, once weekly until disease progression.
|
|---|---|---|
|
Combination Treatment Phase
Progressive Disease (Radiographic test)
|
3
|
3
|
|
Combination Treatment Phase
Progressive Disease(Clinical assessment)
|
0
|
1
|
|
Combination Treatment Phase
Investigator Discretion
|
1
|
1
|
|
Combination Treatment Phase
Withdrawal by Subject
|
4
|
2
|
|
Combination Treatment Phase
Test Article Held (Greater than 21 Days)
|
4
|
1
|
|
Combination Treatment Phase
Adverse Event
|
12
|
4
|
|
Combination Treatment Phase
Death
|
1
|
1
|
|
Combination Treatment Phase
Sponsor Decision
|
0
|
12
|
|
Combination Treatment Phase
Other
|
1
|
0
|
|
Combination Treatment Phase
Not treated
|
0
|
2
|
|
Maintenance Treatment Phase
Progressive Disease (Radiographic test)
|
15
|
10
|
|
Maintenance Treatment Phase
Withdrawal by Subject
|
0
|
1
|
|
Maintenance Treatment Phase
Test Article Held (Greater than 21 Days)
|
10
|
0
|
|
Maintenance Treatment Phase
Adverse Event
|
0
|
3
|
|
Maintenance Treatment Phase
Sponsor Decision
|
0
|
15
|
|
Maintenance Treatment Phase
Not Treated
|
1
|
0
|
Baseline Characteristics
Study of the Safety and Efficacy of Amatuximab in Combination With Pemetrexed and Cisplatin in Subjects With Unresectable Malignant Pleural Mesothelioma (MPM)
Baseline characteristics by cohort
| Measure |
Amatuximab + Pemetrexed + Cisplatin
n=52 Participants
During Combination Treatment Phase, participants received amatuximab 5 mg/kg, infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles. Following completion of the Combination Treatment Phase, participants who had not progressed entered the Maintenance Phase and continued to receive amatuximab 5 mg/kg, infusion, intravenously, once weekly until disease progression.
|
Placebo + Pemetrexed + Cisplatin
n=54 Participants
During Combination Treatment Phase, participants received placebo matched to amatuximab infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles. Following completion of the Combination Treatment Phase, participants who had not progressed entered the Maintenance Phase and received placebo matched to amatuximab infusion, intravenously, once weekly until disease progression.
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.9 years
STANDARD_DEVIATION 6.08 • n=5 Participants
|
66.9 years
STANDARD_DEVIATION 7.96 • n=7 Participants
|
67.4 years
STANDARD_DEVIATION 7.08 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 3 yearsPopulation: The safety analysis set was defined as all randomized participants who received at least 1 dose of study drug.
AEs included both non-SAEs and SAEs and the same participant can have both SAEs and as well non-SAEs.
Outcome measures
| Measure |
Combination Treatment Phase:Amatuximab + Pemetrexed +Cisplatin
n=52 Participants
During Combination Treatment Phase, participants received amatuximab 5 mg/kg, infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles.
|
Combination Treatment Phase: Placebo + Pemetrexed + Cisplatin
n=54 Participants
During Combination Treatment Phase, participants received placebo matched to amatuximab infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles.
|
Maintenance Treatment Phase: Amatuximab
n=25 Participants
Following completion of the Combination Treatment Phase, participants who had not progressed entered the Maintenance Phase and continued to receive amatuximab 5 mg/kg, infusion, intravenously, once weekly until disease progression.
|
Maintenance Treatment Phase: Placebo
n=29 Participants
Following completion of the Combination Treatment Phase, participants who had not progressed entered the Maintenance Phase and received placebo matched to amatuximab infusion, intravenously, once weekly until disease progression.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
50 Participants
|
52 Participants
|
19 Participants
|
21 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
15 Participants
|
11 Participants
|
1 Participants
|
4 Participants
|
Adverse Events
Combination Treatment Phase:Amatuximab + Pemetrexed +Cisplatin
Serious events: 15 serious events
Other events: 50 other events
Deaths: 6 deaths
Combination Treatment Phase: Placebo + Pemetrexed + Cisplatin
Serious events: 11 serious events
Other events: 51 other events
Deaths: 3 deaths
Maintenance Treatment Phase: Amatuximab
Serious events: 1 serious events
Other events: 19 other events
Deaths: 2 deaths
Maintenance Treatment Phase: Placebo
Serious events: 4 serious events
Other events: 21 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Combination Treatment Phase:Amatuximab + Pemetrexed +Cisplatin
n=52 participants at risk
During Combination Treatment Phase, participants received amatuximab 5 mg/kg, infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles.
|
Combination Treatment Phase: Placebo + Pemetrexed + Cisplatin
n=54 participants at risk
During Combination Treatment Phase, participants received placebo matched to amatuximab infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles.
|
Maintenance Treatment Phase: Amatuximab
n=25 participants at risk
Following completion of the Combination Treatment Phase, participants who had not progressed entered the Maintenance Phase and continued to receive amatuximab 5 mg/kg, infusion, intravenously, once weekly until disease progression.
|
Maintenance Treatment Phase: Placebo
n=29 participants at risk
Following completion of the Combination Treatment Phase, participants who had not progressed entered the Maintenance Phase and received placebo matched to amatuximab infusion, intravenously, once weekly until disease progression.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/52 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/54 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
3.4%
1/29 • Number of events 2 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/52 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
3.7%
2/54 • Number of events 2 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.9%
1/52 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/54 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/52 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
1.9%
1/54 • Number of events 2 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/52 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
1.9%
1/54 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Eye disorders
Amaurosis
|
0.00%
0/52 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/54 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
4.0%
1/25 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.9%
1/52 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/54 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Gastrointestinal disorders
Colitis
|
1.9%
1/52 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/54 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.8%
2/52 • Number of events 2 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
1.9%
1/54 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Gastrointestinal disorders
Dysphagia
|
1.9%
1/52 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/54 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
3.4%
1/29 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Gastrointestinal disorders
Nausea
|
5.8%
3/52 • Number of events 3 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
3.7%
2/54 • Number of events 2 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/52 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
3.7%
2/54 • Number of events 2 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
General disorders
Chills
|
1.9%
1/52 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/54 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
General disorders
Fatigue
|
1.9%
1/52 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/54 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
General disorders
General physical health deterioration
|
1.9%
1/52 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
1.9%
1/54 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/52 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
1.9%
1/54 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
General disorders
Pyrexia
|
1.9%
1/52 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
1.9%
1/54 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Immune system disorders
Anaphylactic reaction
|
1.9%
1/52 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/54 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Infections and infestations
Cellulitis
|
1.9%
1/52 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/54 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Infections and infestations
Lower respiratory tract infection
|
3.8%
2/52 • Number of events 2 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/54 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Infections and infestations
Lung infection
|
0.00%
0/52 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
1.9%
1/54 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Infections and infestations
Mucosal infection
|
1.9%
1/52 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/54 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/52 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/54 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
3.4%
1/29 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Infections and infestations
Urinary tract infection
|
3.8%
2/52 • Number of events 2 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/54 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
3.8%
2/52 • Number of events 2 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
1.9%
1/54 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.9%
1/52 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/54 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.9%
1/52 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
1.9%
1/54 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
1.9%
1/52 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/54 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Nervous system disorders
Syncope
|
0.00%
0/52 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
1.9%
1/54 • Number of events 2 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Psychiatric disorders
Organic brain syndrome
|
0.00%
0/52 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/54 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
3.4%
1/29 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.9%
1/52 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
3.7%
2/54 • Number of events 2 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
3.4%
1/29 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Renal and urinary disorders
Renal failure
|
1.9%
1/52 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
1.9%
1/54 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/52 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
3.7%
2/54 • Number of events 2 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.9%
1/52 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/54 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Vascular disorders
Deep vein thrombosis
|
1.9%
1/52 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/54 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
Other adverse events
| Measure |
Combination Treatment Phase:Amatuximab + Pemetrexed +Cisplatin
n=52 participants at risk
During Combination Treatment Phase, participants received amatuximab 5 mg/kg, infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles.
|
Combination Treatment Phase: Placebo + Pemetrexed + Cisplatin
n=54 participants at risk
During Combination Treatment Phase, participants received placebo matched to amatuximab infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles.
|
Maintenance Treatment Phase: Amatuximab
n=25 participants at risk
Following completion of the Combination Treatment Phase, participants who had not progressed entered the Maintenance Phase and continued to receive amatuximab 5 mg/kg, infusion, intravenously, once weekly until disease progression.
|
Maintenance Treatment Phase: Placebo
n=29 participants at risk
Following completion of the Combination Treatment Phase, participants who had not progressed entered the Maintenance Phase and received placebo matched to amatuximab infusion, intravenously, once weekly until disease progression.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
21.2%
11/52 • Number of events 29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
22.2%
12/54 • Number of events 21 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
12.0%
3/25 • Number of events 11 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
6.9%
2/29 • Number of events 2 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.8%
3/52 • Number of events 3 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
1.9%
1/54 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Blood and lymphatic system disorders
Neutropenia
|
25.0%
13/52 • Number of events 35 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
18.5%
10/54 • Number of events 28 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
8.0%
2/25 • Number of events 2 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.6%
5/52 • Number of events 7 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
1.9%
1/54 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
4.0%
1/25 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Ear and labyrinth disorders
Tinnitus
|
9.6%
5/52 • Number of events 6 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
5.6%
3/54 • Number of events 4 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Eye disorders
Dry eye
|
5.8%
3/52 • Number of events 3 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
3.7%
2/54 • Number of events 2 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Eye disorders
Lacrimation increased
|
7.7%
4/52 • Number of events 5 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
1.9%
1/54 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
3.4%
1/29 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.8%
3/52 • Number of events 3 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
3.7%
2/54 • Number of events 4 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
8.0%
2/25 • Number of events 2 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.8%
2/52 • Number of events 5 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
9.3%
5/54 • Number of events 5 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
4.0%
1/25 • Number of events 2 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
3.4%
1/29 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Gastrointestinal disorders
Constipation
|
32.7%
17/52 • Number of events 27 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
40.7%
22/54 • Number of events 32 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
4.0%
1/25 • Number of events 2 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
6.9%
2/29 • Number of events 2 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Gastrointestinal disorders
Diarrhoea
|
21.2%
11/52 • Number of events 17 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
18.5%
10/54 • Number of events 13 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
12.0%
3/25 • Number of events 3 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Gastrointestinal disorders
Dyspepsia
|
13.5%
7/52 • Number of events 8 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
16.7%
9/54 • Number of events 10 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
4.0%
1/25 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Gastrointestinal disorders
Nausea
|
65.4%
34/52 • Number of events 78 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
72.2%
39/54 • Number of events 83 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
4.0%
1/25 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
10.3%
3/29 • Number of events 4 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Gastrointestinal disorders
Stomatitis
|
11.5%
6/52 • Number of events 7 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
24.1%
13/54 • Number of events 21 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
13/52 • Number of events 25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
33.3%
18/54 • Number of events 34 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
8.0%
2/25 • Number of events 2 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
10.3%
3/29 • Number of events 5 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
General disorders
Asthenia
|
21.2%
11/52 • Number of events 18 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
33.3%
18/54 • Number of events 48 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
4.0%
1/25 • Number of events 8 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
20.7%
6/29 • Number of events 9 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
General disorders
Chills
|
11.5%
6/52 • Number of events 6 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
1.9%
1/54 • Number of events 2 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
3.4%
1/29 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
General disorders
Fatigue
|
34.6%
18/52 • Number of events 27 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
35.2%
19/54 • Number of events 31 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
12.0%
3/25 • Number of events 3 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
6.9%
2/29 • Number of events 3 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
General disorders
Non-cardiac chest pain
|
7.7%
4/52 • Number of events 5 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
5.6%
3/54 • Number of events 3 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
8.0%
2/25 • Number of events 2 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
6.9%
2/29 • Number of events 3 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
General disorders
Oedema peripheral
|
5.8%
3/52 • Number of events 3 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
5.6%
3/54 • Number of events 6 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
6.9%
2/29 • Number of events 2 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
General disorders
Pyrexia
|
13.5%
7/52 • Number of events 8 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
5.6%
3/54 • Number of events 5 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
3.4%
1/29 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Infections and infestations
Conjunctivitis
|
7.7%
4/52 • Number of events 6 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
7.4%
4/54 • Number of events 7 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Infections and infestations
Nasopharyngitis
|
7.7%
4/52 • Number of events 4 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
1.9%
1/54 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
12.0%
3/25 • Number of events 3 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
3.4%
1/29 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
11.5%
6/52 • Number of events 9 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/54 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/52 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
5.6%
3/54 • Number of events 3 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/52 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
5.6%
3/54 • Number of events 3 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Investigations
Blood creatinine increased
|
5.8%
3/52 • Number of events 5 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
11.1%
6/54 • Number of events 7 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
6.9%
2/29 • Number of events 2 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
26.9%
14/52 • Number of events 23 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
31.5%
17/54 • Number of events 25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
4.0%
1/25 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
6.9%
2/29 • Number of events 2 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.8%
3/52 • Number of events 3 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
3.7%
2/54 • Number of events 2 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.8%
3/52 • Number of events 4 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
5.6%
3/54 • Number of events 3 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
3.8%
2/52 • Number of events 2 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
5.6%
3/54 • Number of events 3 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.9%
1/52 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
5.6%
3/54 • Number of events 5 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.8%
2/52 • Number of events 4 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
9.3%
5/54 • Number of events 6 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
4.0%
1/25 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
3.8%
2/52 • Number of events 2 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
3.7%
2/54 • Number of events 2 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
8.0%
2/25 • Number of events 2 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
3.4%
1/29 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
1.9%
1/52 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
5.6%
3/54 • Number of events 4 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
3.4%
1/29 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Nervous system disorders
Dysgeusia
|
9.6%
5/52 • Number of events 5 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
11.1%
6/54 • Number of events 8 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
3.4%
1/29 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Nervous system disorders
Headache
|
11.5%
6/52 • Number of events 6 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
7.4%
4/54 • Number of events 4 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
4.0%
1/25 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
3.4%
1/29 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Nervous system disorders
Paraesthesia
|
13.5%
7/52 • Number of events 9 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
3.7%
2/54 • Number of events 3 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
12.0%
3/25 • Number of events 4 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
3.4%
1/29 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
3.8%
2/52 • Number of events 2 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
9.3%
5/54 • Number of events 9 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
13.8%
4/29 • Number of events 6 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Nervous system disorders
Tremor
|
3.8%
2/52 • Number of events 2 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
5.6%
3/54 • Number of events 3 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
3.4%
1/29 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Psychiatric disorders
Anxiety
|
7.7%
4/52 • Number of events 4 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
1.9%
1/54 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Psychiatric disorders
Insomnia
|
5.8%
3/52 • Number of events 3 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
7.4%
4/54 • Number of events 4 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.4%
8/52 • Number of events 12 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
11.1%
6/54 • Number of events 6 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
16.0%
4/25 • Number of events 7 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
17.2%
5/29 • Number of events 6 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
17.3%
9/52 • Number of events 10 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
5.6%
3/54 • Number of events 4 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
16.0%
4/25 • Number of events 7 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.7%
4/52 • Number of events 5 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
3.7%
2/54 • Number of events 2 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
4.0%
1/25 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
1.9%
1/52 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
5.6%
3/54 • Number of events 3 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.7%
4/52 • Number of events 4 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
5.6%
3/54 • Number of events 3 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
8.0%
2/25 • Number of events 2 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
6.9%
2/29 • Number of events 3 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
5.8%
3/52 • Number of events 3 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
1.9%
1/54 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.9%
1/52 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
5.6%
3/54 • Number of events 3 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
4.0%
1/25 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
3.4%
1/29 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.8%
2/52 • Number of events 2 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
7.4%
4/54 • Number of events 4 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
4.0%
1/25 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
3.4%
1/29 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
3.8%
2/52 • Number of events 2 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
1.9%
1/54 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
4.0%
1/25 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
6.9%
2/29 • Number of events 2 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.8%
3/52 • Number of events 3 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/54 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.5%
6/52 • Number of events 6 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
13.0%
7/54 • Number of events 10 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
8.0%
2/25 • Number of events 2 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Vascular disorders
Hypertension
|
5.8%
3/52 • Number of events 6 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/54 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
3.4%
1/29 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Vascular disorders
Hypotension
|
7.7%
4/52 • Number of events 4 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/54 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
3.4%
1/29 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/52 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/54 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
6.9%
2/29 • Number of events 2 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Infections and infestations
Influenza
|
0.00%
0/52 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/54 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
8.0%
2/25 • Number of events 2 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/52 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/54 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
8.0%
2/25 • Number of events 2 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
1.9%
1/52 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/54 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
8.0%
2/25 • Number of events 2 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/29 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/52 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
1.9%
1/54 • Number of events 1 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/25 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
6.9%
2/29 • Number of events 2 • From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place